<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/NCT03035409</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0655</org_study_id>
    <secondary_id>NCI-2017-00188</secondary_id>
    <secondary_id>2016-0655</secondary_id>
    <nct_id>NCT03035409</nct_id>
  </id_info>
  <brief_title>Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors</brief_title>
  <official_title>Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This phase II trial studies how well anamorelin hydrochloride, physical activity, and&#xD;
      nutritional counseling work in decreasing cancer-related fatigue in patients with incurable&#xD;
      solid tumors that have spread to other parts of the body or have come back. Anamorelin&#xD;
      hydrochloride, physical activity, and nutritional counseling may help to decrease&#xD;
      cancer-related fatigue in patients with solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue&#xD;
      (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced&#xD;
      cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized&#xD;
      physical activity and nutritional counseling.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To examine the effects of anamorelin and standardized physical activity and nutritional&#xD;
      counseling on health-related quality of life and patient reported outcomes as measured by the&#xD;
      Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes&#xD;
      Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS),&#xD;
      Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G)&#xD;
      and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these&#xD;
      patients.&#xD;
&#xD;
      II. To examine the side effects and tolerability of anamorelin in these patients.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To explore the effects of anamorelin and standardized physical activity and nutritional&#xD;
      counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk&#xD;
      test, day time activity [accelerometer], body composition [as measured by INBODY], and&#xD;
      resting energy expenditure [measured by indirect calorimetry]).&#xD;
&#xD;
      II. To characterize the effects of anamorelin on potential inflammatory biomarkers of&#xD;
      cancer-related fatigue (CRF) (C-Reactive Protein [CRP], monocyte IL-6&amp;R, TNF-a&amp;R, IL-10,&#xD;
      IL-8, IL-1&amp;RA; IGF-1).&#xD;
&#xD;
      III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep&#xD;
      Quality Index (PSQI).&#xD;
&#xD;
      IV. To determine the association between change in FACIT-F scores and changes in muscle&#xD;
      function, day time activity, and body composition, in patients with advanced cancer receiving&#xD;
      oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical&#xD;
      activity consisting of resistance exercises and a home walking program. Treatment continues&#xD;
      for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients&#xD;
      also undergo nutritional counseling on day 21.&#xD;
&#xD;
      After completion of study treatment, patients are followed up on day 71.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2026</completion_date>
  <primary_completion_date type="Actual">December 27, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)</measure>
    <time_frame>Baseline up to day 43</time_frame>
    <description>FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Edmonton Symptom Assessment Scale (ESAS)-Fatigue</measure>
    <time_frame>Baseline up to day 43</time_frame>
    <description>The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue</measure>
    <time_frame>Baseline up to day 43</time_frame>
    <description>The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 (&quot;not at all&quot;) to 4 (&quot;extremely fatigue&quot;). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue</measure>
    <time_frame>Baseline up to day 43</time_frame>
    <description>The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 (&quot;not at all&quot;) to 4 (&quot;extremely fatigue&quot;). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Advanced Malignant Solid Neoplasm</condition>
  <condition>C-Reactive Protein Measurement</condition>
  <condition>Cancer Fatigue</condition>
  <condition>Metastatic Malignant Solid Neoplasm</condition>
  <condition>Recurrent Malignant Solid Neoplasm</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anamorelin Hydrochloride</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
    <other_name>RC-1291 HCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Undergo physical activity</description>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional Assessment</intervention_name>
    <description>Undergo nutritional counseling</description>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
    <other_name>Dietary Assessment</other_name>
    <other_name>dietary counseling</other_name>
    <other_name>nutritional counseling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (anamorelin, physical activity, counseling)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid&#xD;
             tumors excluding prostate cancer)&#xD;
&#xD;
          -  Presence of fatigue on FACIT-F subscale of =&lt; 34 on a 0 to 52 scale (in which 52 = no&#xD;
             fatigue and 0 = worst possible fatigue)&#xD;
&#xD;
          -  Patient should describe fatigue as being present for a minimum of 2 weeks prior to&#xD;
             screening&#xD;
&#xD;
          -  CRP must be &gt;= 3 mg/l in the absence of any other more likely cause of increased CRP&#xD;
             like an infection or an autoimmune disorder&#xD;
&#xD;
          -  No evidence of moderate to severe depression as determined by a HADS depression score&#xD;
             of =&lt; 13&#xD;
&#xD;
          -  Presence of unintentional weight loss ranging from &gt;= 2 - =&lt; 15% in last 12 months&#xD;
&#xD;
          -  Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she&#xD;
             must have had no major dose change (&gt; 25%) for at least 48 hours prior to study entry;&#xD;
             the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by&#xD;
             the principal investigator (PI); change in opioid dose after study entry is allowed&#xD;
&#xD;
          -  Patient must be willing to engage in telephone follow up with research staff&#xD;
&#xD;
          -  Patient must have telephone access to be contacted by the research staff&#xD;
&#xD;
          -  Hemoglobin level of &gt;= 9 g/dL&#xD;
&#xD;
          -  Estimated life expectancy of &gt; 4 months at the time of screening&#xD;
&#xD;
          -  Aspartate transaminase (AST) and alanine transaminase (ALT) levels =&lt; 5 x upper limit&#xD;
             of normal (ULN)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major contraindications to anamorelin e.g. hypersensitivity&#xD;
&#xD;
          -  Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a&#xD;
             week&#xD;
&#xD;
          -  Inability to complete the baseline assessment forms or to understand the&#xD;
             recommendations for participation in the study&#xD;
&#xD;
          -  Pregnant or lactating women, childbearing age women who are not on birth control;&#xD;
             negative pregnancy test for women of childbearing potential, as defined by intact&#xD;
             uterus and ovaries, and a history of menses within the last 12 months; pregnancy test&#xD;
             to be performed no greater than 14 days prior to consent in study; in cases of women&#xD;
             with elevated b-HCG, these candidates will be eligible to participate so long as the&#xD;
             level of b-HCG is not consistent with pregnancy; women of childbearing potential need&#xD;
             to be on or use contraception, or be abstinent during the study period; their male&#xD;
             partners must also use contraception (condom) or maintain abstinence; birth controls&#xD;
             specifications: women who are able to become pregnant must use birth control during&#xD;
             the study and for 30 days after the last anamorelin dose; acceptable forms of birth&#xD;
             control include barrier methods (such as condom or diaphragm) with spermicide&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus (fasting blood sugar &gt; 200 mg/dl) at screening&#xD;
&#xD;
          -  Male patients with a history of untreated hypogonadism&#xD;
&#xD;
          -  Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks&#xD;
             (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)&#xD;
&#xD;
          -  Patients on drugs that may prolong the PR or QRS interval durations, such as any of&#xD;
             the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided&#xD;
             (e.g. flecainide, procainamide, propafenone, quinidine)&#xD;
&#xD;
          -  Patients with untreated clinically relevant hypothyroidism&#xD;
&#xD;
          -  Patients currently on investigational therapies will be evaluated by the PI on a case&#xD;
             by case basis and study participation approval will be obtained from the treating&#xD;
             oncologist&#xD;
&#xD;
          -  Patients with prostate cancer&#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>Sriram Yennu</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D 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>May 2023</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>December 3, 2021</results_first_submitted>
  <results_first_submitted_qc>January 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 3, 2022</results_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_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>September 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03035409/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients with advanced cancer were recruited from the Supportive Care Center of MD Anderson Cancer Center with a fatigue score of &lt; =34 on a 0 to 52 scale (FACIT-F) present for a minimum of 2 weeks before screening. Participants were recruited between February 2017 and December 2019.</recruitment_details>
      <pre_assignment_details>129 participants were enrolled in this study but 45 participants received the treatment. 84 participants did not receive treatment due to either screen failure or not eligible to receive treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Anamorelin</title>
          <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 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="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Day 15</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Day 29</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Day 43</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non compliance</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient was jittery</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not like Questionnaire</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Aspartate Aminotransferase increased</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not like taking drugs</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Anamorelin</title>
          <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </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="64" lower_limit="39" upper_limit="87"/>
                  </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="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="28"/>
                  </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>Lung</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breast</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gynecological</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Full time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retired</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homemaker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unemployed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Divorced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Single / never married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)</title>
        <description>FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.</description>
        <time_frame>Baseline up to day 43</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anamorelin</title>
            <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)</title>
          <description>FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.</description>
          <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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.89" lower_limit="-0.18" upper_limit="9.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Edmonton Symptom Assessment Scale (ESAS)-Fatigue</title>
        <description>The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.</description>
        <time_frame>Baseline up to day 43</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anamorelin</title>
            <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.</description>
          </group>
        </group_list>
        <measure>
          <title>The Edmonton Symptom Assessment Scale (ESAS)-Fatigue</title>
          <description>The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.</description>
          <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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.81" lower_limit="-1.95" upper_limit="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue</title>
        <description>The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 (&quot;not at all&quot;) to 4 (&quot;extremely fatigue&quot;). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.</description>
        <time_frame>Baseline up to day 43</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anamorelin</title>
            <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue</title>
          <description>The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 (&quot;not at all&quot;) to 4 (&quot;extremely fatigue&quot;). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.</description>
          <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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.46" lower_limit="-6.21" upper_limit="-0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue</title>
        <description>The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 (&quot;not at all&quot;) to 4 (&quot;extremely fatigue&quot;). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.</description>
        <time_frame>Baseline up to day 43</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anamorelin</title>
            <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue</title>
          <description>The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 (&quot;not at all&quot;) to 4 (&quot;extremely fatigue&quot;). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.</description>
          <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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" lower_limit="-2.34" upper_limit="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>adverse events were collected at baseline to Day 43</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Anamorelin</title>
          <description>Participants received Anamorelin 100mg tablet orally daily with standardized exercise prescription and nutritional support for 43 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="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>CTCAE 4.0</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="10" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Arthalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rash maculopapular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </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>Dr. Sriram Yennu, Professor, Palliative Care Med</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 792-3938</phone>
      <email>syennu@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/NCT03035409
org study id: 2016-0655
secondary id: NCI-2017-00188
secondary id: 2016-0655
nct id: NCT03035409
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well anamorelin hydrochloride, physical activity, and
      nutritional counseling work in decreasing cancer-related fatigue in patients with incurable
      solid tumors that have spread to other parts of the body or have come back. Anamorelin
      hydrochloride, physical activity, and nutritional counseling may help to decrease
      cancer-related fatigue in patients with solid tumors.
PRIMARY OBJECTIVES:

      I. To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue
      (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced
      cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized
      physical activity and nutritional counseling.

      SECONDARY OBJECTIVES:

      I. To examine the effects of anamorelin and standardized physical activity and nutritional
      counseling on health-related quality of life and patient reported outcomes as measured by the
      Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes
      Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS),
      Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G)
      and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these
      patients.

      II. To examine the side effects and tolerability of anamorelin in these patients.

      EXPLORATORY OBJECTIVES:

      I. To explore the effects of anamorelin and standardized physical activity and nutritional
      counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk
      test, day time activity [accelerometer], body composition [as measured by INBODY], and
      resting energy expenditure [measured by indirect calorimetry]).

      II. To characterize the effects of anamorelin on potential inflammatory biomarkers of
      cancer-related fatigue (CRF) (C-Reactive Protein [CRP], monocyte IL-6&R, TNF-a&R, IL-10,
      IL-8, IL-1&RA; IGF-1).

      III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep
      Quality Index (PSQI).

      IV. To determine the association between change in FACIT-F scores and changes in muscle
      function, day time activity, and body composition, in patients with advanced cancer receiving
      oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.

      OUTLINE:

      Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical
      activity consisting of resistance exercises and a home walking program. Treatment continues
      for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients
      also undergo nutritional counseling on day 21.

      After completion of study treatment, patients are followed up on day 71.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
time frame: Baseline up to day 43
description: FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.
measure: The Edmonton Symptom Assessment Scale (ESAS)-Fatigue
time frame: Baseline up to day 43
description: The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.
measure: Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue
time frame: Baseline up to day 43
description: The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.
measure: Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue
time frame: Baseline up to day 43
description: The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.
arm group label: Supportive Care (anamorelin, physical activity, counseling)
arm group type: Experimental
description: Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
intervention type: Drug
intervention name: Anamorelin Hydrochloride
description: Given PO
arm group label: Supportive Care (anamorelin, physical activity, counseling)
other name: RC-1291 HCl
intervention type: Behavioral
intervention name: Exercise Intervention
description: Undergo physical activity
arm group label: Supportive Care (anamorelin, physical activity, counseling)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Supportive Care (anamorelin, physical activity, counseling)
intervention type: Other
intervention name: Nutritional Assessment
description: Undergo nutritional counseling
arm group label: Supportive Care (anamorelin, physical activity, counseling)
other name: Dietary Assessment
other name: dietary counseling
other name: nutritional counseling
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive Care (anamorelin, physical activity, counseling)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive Care (anamorelin, physical activity, counseling)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sriram Yennu
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: Neoplasms
mesh term: Fatigue
mesh term: Weight Loss
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 