<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01670097</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0001</org_study_id>
    <secondary_id>NCI-2012-01615</secondary_id>
    <nct_id>NCT01670097</nct_id>
  </id_info>
  <brief_title>Dexamethasone Dyspnea Study</brief_title>
  <official_title>A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if dexamethasone can help reduce&#xD;
      shortness of breath in cancer patients. Researchers also want to learn if it can help to&#xD;
      improve lung function and quality of life. In this study, dexamethasone will be compared to a&#xD;
      placebo.&#xD;
&#xD;
      Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help&#xD;
      patients with shortness of breath.&#xD;
&#xD;
      A placebo is not a drug. It looks like the study drug but is not designed to treat any&#xD;
      disease or illness. It is designed to be compared with a study drug to learn if the study&#xD;
      drug has any real effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Baseline Tests:&#xD;
&#xD;
      If you are found to be eligible to take part in this study, you will have baseline tests&#xD;
      after completing the screening questionnaires. The following tests and procedures will be&#xD;
      performed:&#xD;
&#xD;
        -  Information will be collected from your medical record about your age, sex, race,&#xD;
           disease type, how well you are able to perform the normal activities of daily living,&#xD;
           any drugs you are taking, and possible causes of shortness of breath.&#xD;
&#xD;
        -  Your breathing rate will be measured.&#xD;
&#xD;
        -  The amount of oxygen in your body will be measured using a machine that clips on your&#xD;
           finger.&#xD;
&#xD;
        -  You will blow into a device called a spirometer a few times to measure your lung&#xD;
           function.&#xD;
&#xD;
        -  You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate&#xD;
           your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety,&#xD;
           and drowsiness. The second questionnaire asks about your sensation of breathing. The&#xD;
           third questionnaire asks you to rate the intensity of your shortness of breath. The last&#xD;
           questionnaire asks about your quality of life. These questionnaires should take a total&#xD;
           of about 40 minutes to complete.&#xD;
&#xD;
      Study Groups:&#xD;
&#xD;
      You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:&#xD;
&#xD;
        -  If you are in Group 1, you will receive dexamethasone.&#xD;
&#xD;
        -  If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7&#xD;
           days.&#xD;
&#xD;
      You will have an equal chance of being assigned to either group. Neither you nor the study&#xD;
      staff will know if you are receiving the study drug or the placebo. However, if needed for&#xD;
      your safety, the study staff will be able to find out what you are receiving.&#xD;
&#xD;
      Study Drug/Placebo Administration:&#xD;
&#xD;
      After your baseline tests, you will be given a supply of either the study drug or the placebo&#xD;
      to bring home.&#xD;
&#xD;
      Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by&#xD;
      mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.&#xD;
&#xD;
      After the first 7 days, no matter which group you have been assigned to, you will only take 1&#xD;
      dexamethasone capsule twice a day for 7 more days&#xD;
&#xD;
      You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon.&#xD;
      You should take the capsules with food and 8 ounces of water.&#xD;
&#xD;
      You will also receive a portable spirometer to test your lung function. You should blow into&#xD;
      the machine 1 time a day.&#xD;
&#xD;
      Study Visits/Calls:&#xD;
&#xD;
      On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your&#xD;
      capsule boxes with you if you come to the clinic, or have them with you if you are called so&#xD;
      the study staff can count the number of capsules. The following tests and procedures will be&#xD;
      performed:&#xD;
&#xD;
        -  You will be asked to complete the same 4 questionnaires you completed during your&#xD;
           baseline tests.&#xD;
&#xD;
        -  You will also be asked about any side effects you may be having and if you think the&#xD;
           study drug is helping your shortness of breath.&#xD;
&#xD;
        -  You will blow into a spirometer to measure your lung function.&#xD;
&#xD;
      During the 14 days you will be taking either the study drug or the placebo on the study, you&#xD;
      will be called by phone 1 time each day to ask you about your level of shortness of breath&#xD;
      and to remind you to take the capsules. These calls should last about 5 minutes.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is&#xD;
      in your best interest. You will no longer be able to take the study drug if intolerable side&#xD;
      effects occur or if you are unable to follow study directions.&#xD;
&#xD;
      Your participation on the study will be over when you have completed the follow-up calls and&#xD;
      visit.&#xD;
&#xD;
      This is an investigational study. Dexamethasone is FDA approved and commercially available&#xD;
      for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath&#xD;
      is investigational.&#xD;
&#xD;
      Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">January 26, 2021</completion_date>
  <primary_completion_date type="Actual">August 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Dyspnea Numeric Rating Scale</measure>
    <time_frame>Baseline to Day 7</time_frame>
    <description>Number of participants who completed the dyspnea numeric rating scale on Day 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Edmonton Symptom Assessment System Dyspnea Score</measure>
    <time_frame>Baseline to Day 4, Day 7, Day 14</time_frame>
    <description>The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea Numeric Rating Score (Now)</measure>
    <time_frame>Baseline to day 4, Day 7 and Day 14</time_frame>
    <description>Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea</measure>
    <time_frame>Baseline to day 4, Day 7 and Day 14.</time_frame>
    <description>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week (&quot;Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Advanced Cancers</condition>
  <condition>Hematologic Disorder</condition>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.&#xD;
Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.&#xD;
Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.&#xD;
Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Sugar pill</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spirometer</intervention_name>
    <description>Patient to blow into spirometry machine 1 time a day to test lung function.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phone Calls</intervention_name>
    <description>Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of cancer&#xD;
&#xD;
          2. Dyspnea with an average intensity level &gt;3/10 on the numeric rating scale over the&#xD;
             past week&#xD;
&#xD;
          3. Clinical or radiologic history of lung/pleural involvement (primary or metastatic),&#xD;
             lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration&#xD;
&#xD;
          4. Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation&#xD;
             Service, Thoracic Oncology or Pulmonary Medicine&#xD;
&#xD;
          5. Able to communicate in English&#xD;
&#xD;
          6. Karnofsky performance status &gt;=40%&#xD;
&#xD;
          7. Age 18 or older&#xD;
&#xD;
          8. Permission from the attending medical oncologist if the patient is currently on an&#xD;
             interventional cancer therapy trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Delirium (i.e. Memorial delirium rating scale &gt;13)&#xD;
&#xD;
          2. Oxygen saturation &lt;90% despite supplemental oxygen &gt;6L/min&#xD;
&#xD;
          3. Previous allergic reactions to dexamethasone&#xD;
&#xD;
          4. Uncontrolled hyperglycemia as defined by any blood glucose of &gt;300 mg/dl in the past&#xD;
             two weeks&#xD;
&#xD;
          5. Severe anemia (Hb &lt;7g/L) not corrected prior to study enrollment (bloodwork is not&#xD;
             required if patient did not have recent chemotherapy within last 2 weeks)&#xD;
&#xD;
          6. Post-surgical open wound that has not been healed at the time of enrollment&#xD;
&#xD;
          7. Any infection requiring parenteral antibiotics within the past 2 weeks&#xD;
&#xD;
          8. Major surgery within the past 2 weeks&#xD;
&#xD;
          9. Megestrol use at the time of study enrollment&#xD;
&#xD;
         10. Neutropenia (absolute neutrophil count &lt; 1.0) (bloodwork is not required if patient&#xD;
             did not have recent chemotherapy within last 2 weeks)&#xD;
&#xD;
         11. Currently on or expected to start cytotoxic chemotherapy with in 1 week of study&#xD;
             enrollment&#xD;
&#xD;
         12. Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study&#xD;
             enrollment&#xD;
&#xD;
         13. Heart failure exacerbation at the time of study enrollment&#xD;
&#xD;
         14. Chronic systemic corticosteroid use (&gt;14 days) at the time of study enrollment&#xD;
&#xD;
         15. Unwilling to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Hui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>October 15, 2020</results_first_submitted>
  <results_first_submitted_qc>January 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2021</results_first_posted>
  <last_update_submitted>January 31, 2021</last_update_submitted>
  <last_update_submitted_qc>January 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced Cancers</keyword>
  <keyword>Hematologic Disorder</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>Dyspnea</keyword>
  <keyword>Difficulty breathing</keyword>
  <keyword>Shortness of breath</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>Decadron</keyword>
  <keyword>Placebo</keyword>
  <keyword>Sugar pill</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>Spirometer</keyword>
  <keyword>Phone calls</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 14, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT01670097/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Adult cancer patient with lung involvement were recruited between 1/2013 and 5/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.</recruitment_details>
      <pre_assignment_details>A total of 52 participants enrolled for this study. Among them, 41 patients were randomized. 6 participants declined to continue and 5 participants became ineligible (3 started steroids, 2 had other reasons) before randomization, thus a total of 11 participants were dropped out before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group (Dexamethasone)</title>
          <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
        </group>
        <group group_id="P2">
          <title>Controlled Group (Placebo)</title>
          <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 1 Intervention</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 2 Intervention</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Started Phase 1 cancer treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study burden</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COPD exacerbation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Neutropenia</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Clinical deterioration</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data included all participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group (Dexamethasone)</title>
          <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
        </group>
        <group group_id="B2">
          <title>Controlled Group (Placebo)</title>
          <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" lower_limit="49" upper_limit="71"/>
                    <measurement group_id="B2" value="64" lower_limit="48" upper_limit="78"/>
                    <measurement group_id="B3" value="63" lower_limit="48" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>High School or less</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College and above</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mesothelioma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-small cell lung cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Small cell lung cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Stage</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Localized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Locally advanced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metastatic/recurrent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>COPD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Dyspnea Numeric Rating Scale</title>
        <description>Number of participants who completed the dyspnea numeric rating scale on Day 7</description>
        <time_frame>Baseline to Day 7</time_frame>
        <population>Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Dexamethasone)</title>
            <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Controlled Group (Placebo)</title>
            <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Dyspnea Numeric Rating Scale</title>
          <description>Number of participants who completed the dyspnea numeric rating scale on Day 7</description>
          <population>Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Edmonton Symptom Assessment System Dyspnea Score</title>
        <description>The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.</description>
        <time_frame>Baseline to Day 4, Day 7, Day 14</time_frame>
        <population>The number of participants varied by milestone study days (Baseline (38 participants) , Day 4 (30 participants) , Day 7 (30 participants) and Day 14 (28 participants) who completed the Edmonton Symptom Assessment Questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Dexamethasone)</title>
            <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Controlled Group (Placebo)</title>
            <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Edmonton Symptom Assessment System Dyspnea Score</title>
          <description>The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.</description>
          <population>The number of participants varied by milestone study days (Baseline (38 participants) , Day 4 (30 participants) , Day 7 (30 participants) and Day 14 (28 participants) who completed the Edmonton Symptom Assessment Questionnaire.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-3.3" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-2.1" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-3.2" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-1.3" lower_limit="-2.4" upper_limit="-0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" lower_limit="-3.5" upper_limit="-0.6"/>
                    <measurement group_id="O2" value="-1.7" lower_limit="-2.7" upper_limit="-0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dyspnea Numeric Rating Score (Now)</title>
        <description>Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.</description>
        <time_frame>Baseline to day 4, Day 7 and Day 14</time_frame>
        <population>The number of participants varied by milestone study days (Baseline (38 participants), Day 4, (35 participants) Day 7 (35 participants), and Day 14 (26 participants) who completed the Dyspnea Numeric Rating Score Questionnaire.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Dexamethasone)</title>
            <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Controlled Group (Placebo)</title>
            <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Dyspnea Numeric Rating Score (Now)</title>
          <description>Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.</description>
          <population>The number of participants varied by milestone study days (Baseline (38 participants), Day 4, (35 participants) Day 7 (35 participants), and Day 14 (26 participants) who completed the Dyspnea Numeric Rating Score Questionnaire.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1" upper_limit="1"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-1.1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-2.4" upper_limit="0.2"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-1.6" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" lower_limit="-3" upper_limit="-0.2"/>
                    <measurement group_id="O2" value="-1.5" lower_limit="-2.5" upper_limit="-0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea</title>
        <description>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week (&quot;Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.</description>
        <time_frame>Baseline to day 4, Day 7 and Day 14.</time_frame>
        <population>The number of participants varied by milestone study days (Baseline (38 participants), Day 4 (30 participants), Day 7 (29 participants), and Day 14 (28 participants) who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-20 Dyspnea.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Dexamethasone)</title>
            <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Controlled Group (Placebo)</title>
            <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea</title>
          <description>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week (&quot;Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.</description>
          <population>The number of participants varied by milestone study days (Baseline (38 participants), Day 4 (30 participants), Day 7 (29 participants), and Day 14 (28 participants) who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-20 Dyspnea.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.6" lower_limit="-29.3" upper_limit="-1.8"/>
                    <measurement group_id="O2" value="0" lower_limit="-14" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.4" lower_limit="-21.1" upper_limit="0.3"/>
                    <measurement group_id="O2" value="-5.1" lower_limit="-19" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.7" lower_limit="-22.3" upper_limit="6.9"/>
                    <measurement group_id="O2" value="-6.7" lower_limit="-19.2" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Day 4, Day 7, and Day 14.</time_frame>
      <desc>As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group (Dexamethasone)</title>
          <description>Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
        </group>
        <group group_id="E2">
          <title>Controlled Group (Placebo)</title>
          <description>Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.03)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Halitosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mouth sores</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Taste changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea/vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastric Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title vocab="CTCAE (4.0)">Anxiety/Irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hiccup</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hot flash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Flasing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Hui, MD/ Associate Professor, Palliative Care Medicine</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 792-6258</phone>
      <email>dhui@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670097
org study id: 2012-0001
secondary id: NCI-2012-01615
nct id: NCT01670097
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn if dexamethasone can help reduce
      shortness of breath in cancer patients. Researchers also want to learn if it can help to
      improve lung function and quality of life. In this study, dexamethasone will be compared to a
      placebo.

      Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help
      patients with shortness of breath.

      A placebo is not a drug. It looks like the study drug but is not designed to treat any
      disease or illness. It is designed to be compared with a study drug to learn if the study
      drug has any real effect.
Baseline Tests:

      If you are found to be eligible to take part in this study, you will have baseline tests
      after completing the screening questionnaires. The following tests and procedures will be
      performed:

        -  Information will be collected from your medical record about your age, sex, race,
           disease type, how well you are able to perform the normal activities of daily living,
           any drugs you are taking, and possible causes of shortness of breath.

        -  Your breathing rate will be measured.

        -  The amount of oxygen in your body will be measured using a machine that clips on your
           finger.

        -  You will blow into a device called a spirometer a few times to measure your lung
           function.

        -  You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate
           your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety,
           and drowsiness. The second questionnaire asks about your sensation of breathing. The
           third questionnaire asks you to rate the intensity of your shortness of breath. The last
           questionnaire asks about your quality of life. These questionnaires should take a total
           of about 40 minutes to complete.

      Study Groups:

      You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:

        -  If you are in Group 1, you will receive dexamethasone.

        -  If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7
           days.

      You will have an equal chance of being assigned to either group. Neither you nor the study
      staff will know if you are receiving the study drug or the placebo. However, if needed for
      your safety, the study staff will be able to find out what you are receiving.

      Study Drug/Placebo Administration:

      After your baseline tests, you will be given a supply of either the study drug or the placebo
      to bring home.

      Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by
      mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.

      After the first 7 days, no matter which group you have been assigned to, you will only take 1
      dexamethasone capsule twice a day for 7 more days

      You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon.
      You should take the capsules with food and 8 ounces of water.

      You will also receive a portable spirometer to test your lung function. You should blow into
      the machine 1 time a day.

      Study Visits/Calls:

      On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your
      capsule boxes with you if you come to the clinic, or have them with you if you are called so
      the study staff can count the number of capsules. The following tests and procedures will be
      performed:

        -  You will be asked to complete the same 4 questionnaires you completed during your
           baseline tests.

        -  You will also be asked about any side effects you may be having and if you think the
           study drug is helping your shortness of breath.

        -  You will blow into a spirometer to measure your lung function.

      During the 14 days you will be taking either the study drug or the placebo on the study, you
      will be called by phone 1 time each day to ask you about your level of shortness of breath
      and to remind you to take the capsules. These calls should last about 5 minutes.

      Length of Study:

      You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is
      in your best interest. You will no longer be able to take the study drug if intolerable side
      effects occur or if you are unable to follow study directions.

      Your participation on the study will be over when you have completed the follow-up calls and
      visit.

      This is an investigational study. Dexamethasone is FDA approved and commercially available
      for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath
      is investigational.

      Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Who Completed the Dyspnea Numeric Rating Scale
time frame: Baseline to Day 7
description: Number of participants who completed the dyspnea numeric rating scale on Day 7
measure: Edmonton Symptom Assessment System Dyspnea Score
time frame: Baseline to Day 4, Day 7, Day 14
description: The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.
measure: Dyspnea Numeric Rating Score (Now)
time frame: Baseline to day 4, Day 7 and Day 14
description: Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
time frame: Baseline to day 4, Day 7 and Day 14.
description: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.
arm group label: Dexamethasone
arm group type: Experimental
description: Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.
intervention type: Drug
intervention name: Dexamethasone
description: Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.
Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.
arm group label: Dexamethasone
arm group label: Placebo
other name: Decadron
intervention type: Drug
intervention name: Placebo
description: Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.
arm group label: Placebo
other name: Sugar pill
intervention type: Behavioral
intervention name: Questionnaires
description: Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
arm group label: Dexamethasone
arm group label: Placebo
other name: Surveys
intervention type: Device
intervention name: Spirometer
description: Patient to blow into spirometry machine 1 time a day to test lung function.
arm group label: Dexamethasone
arm group label: Placebo
intervention type: Other
intervention name: Phone Calls
description: Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.
arm group label: Dexamethasone
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Hui, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Dyspnea
mesh term: Hematologic Diseases
mesh term: Dexamethasone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 