<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/NCT01695993</url>
  </required_header>
  <id_info>
    <org_study_id>UCCS1202</org_study_id>
    <secondary_id>R01AT007474-01A1</secondary_id>
    <nct_id>NCT01695993</nct_id>
  </id_info>
  <brief_title>Alternative Approaches for Nausea Control</brief_title>
  <official_title>Alternative Approaches for Nausea Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who&#xD;
      expect to have nausea, will be entered. Participants will be randomized to one of three study&#xD;
      arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure&#xD;
      bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.&#xD;
&#xD;
      Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in&#xD;
      controlling chemotherapy-induced nausea&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Earlier research has shown that the effectiveness of acupressure bands in reducing nausea&#xD;
      could be enhanced by boosting patients' expectations of the bands' efficacy. The present&#xD;
      study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized,&#xD;
      controlled study of 216 breast cancer patients beginning chemotherapy who expect to have&#xD;
      nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2:&#xD;
      Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3:&#xD;
      Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The&#xD;
      investigators hypothesize that acupressure bands provided with the relaxation MP3 will be&#xD;
      effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3&#xD;
      are being examined to determine what is the most effective way to deliver the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">May 16, 2017</completion_date>
  <primary_completion_date type="Actual">May 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Report Nausea Diary</measure>
    <time_frame>five days</time_frame>
    <description>Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = &quot;Not at all nauseated&quot; and at the other end by 7 = &quot;Extremely nauseated.&quot; The outcome variable for the primary analysis was greatest reported nausea from the five day period.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Nausea</condition>
  <arm_group>
    <arm_group_label>Arm 1 - Standard Care Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive standard care only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - Expectancy-neutral Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients receive:&#xD;
Expectancy-neutral handout&#xD;
Expectancy-neutral MP3&#xD;
Acupressure bands</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3 - Expectancy-enhancing Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive:&#xD;
Expectancy-enhancing handout&#xD;
Expectancy-enhancing MP3&#xD;
Acupressure bands</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupressure bands</intervention_name>
    <description>Bilateral acupressure wrist bands</description>
    <arm_group_label>Arm 2 - Expectancy-neutral Arm</arm_group_label>
    <arm_group_label>Arm 3 - Expectancy-enhancing Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Expectancy-neutral handout</intervention_name>
    <description>The expectancy neutral handout has neutral information regarding the acupressure bands</description>
    <arm_group_label>Arm 2 - Expectancy-neutral Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expectancy-neutral MP3</intervention_name>
    <description>Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.</description>
    <arm_group_label>Arm 2 - Expectancy-neutral Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Expectancy-enhancing handout</intervention_name>
    <description>The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands</description>
    <arm_group_label>Arm 3 - Expectancy-enhancing Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expectancy-enhancing MP3</intervention_name>
    <description>Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.</description>
    <arm_group_label>Arm 3 - Expectancy-enhancing Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be female.&#xD;
&#xD;
          -  Have a diagnosis of breast cancer, any stage.&#xD;
&#xD;
          -  Be chemotherapy naïve and about to begin her first course of chemotherapy.&#xD;
&#xD;
          -  Be scheduled to receive one of the following four common chemotherapy regimens with&#xD;
             the specified antiemetic regimen. They are:&#xD;
&#xD;
               1. Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen:&#xD;
                  Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone&#xD;
                  on Days 2 &amp; 3.&#xD;
&#xD;
               2. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen:&#xD;
                  Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone&#xD;
                  on Days 2 &amp; 3.&#xD;
&#xD;
               3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on&#xD;
                  Day 1 + dexamethasone on Days 1, 2, &amp; 3.&#xD;
&#xD;
               4. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen:&#xD;
                  Palonosetron on Day 1 + dexamethasone on Days 1, 2, &amp; 3.&#xD;
&#xD;
        Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or&#xD;
        ondansetron, on one or more days, will be allowed in place of palonosetron.&#xD;
&#xD;
          -  Have a response of &gt; 3 or greater on a question assessing expected nausea as assessed&#xD;
             on a 5-point Likert-scale anchored at one end by 1 = &quot;I am certain I WILL NOT have&#xD;
             this,&quot; and at the other end by 5 = &quot;I am certain I WILL have this.&quot;&#xD;
&#xD;
          -  Be able to read English (since the assessment materials are in printed format).&#xD;
&#xD;
          -  Be 18 years of age or older and give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain&#xD;
             metastases, as determined by their treating oncologist.&#xD;
&#xD;
          -  Be receiving concurrent radiotherapy or interferon.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph A Roscoe, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology-Oncology Associates of Central New York</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester General Hospital's Lipson Cancer and Blood Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester James P. Wilmot Cancer Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>March 27, 2018</results_first_submitted>
  <results_first_submitted_qc>April 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2018</results_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Joseph Roscoe</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Nausea</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Expectancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>January 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT01695993/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm 1</title>
          <description>Patients receive standard care only</description>
        </group>
        <group group_id="P2">
          <title>Arm 2</title>
          <description>Handout without expectancy- enhancing component Relaxation MP3 without expectancy-enhancing component&#xD;
- Acupressure bands</description>
        </group>
        <group group_id="P3">
          <title>Arm 3</title>
          <description>Handout with expectancy- enhancing component Relaxation MP3 with expectancy- enhancing component Acupressure bands</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="75"/>
                <participants group_id="P3" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>To ill to continue</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Changed Medical Facility</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm 1</title>
          <description>Patients will receive only standard care</description>
        </group>
        <group group_id="B2">
          <title>Arm 2</title>
          <description>Handout without expectancy- enhancing component&#xD;
Relaxation MP3 without expectancy-enhancing component&#xD;
Acupressure bands</description>
        </group>
        <group group_id="B3">
          <title>Arm 3</title>
          <description>Handout with expectancy- enhancing component&#xD;
Relaxation MP3 with expectancy-enhancing component&#xD;
Acupressure bands</description>
        </group>
        <group group_id="B4">
          <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="76"/>
            <count group_id="B2" value="75"/>
            <count group_id="B3" value="75"/>
            <count group_id="B4" value="226"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.2" spread="11.5"/>
                    <measurement group_id="B2" value="53.2" spread="11.6"/>
                    <measurement group_id="B3" value="52.6" spread="10.5"/>
                    <measurement group_id="B4" value="53" spread="11.2"/>
                  </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="76"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="220"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="199"/>
                  </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 group_id="B4" 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="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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="76"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Report Nausea Diary</title>
        <description>Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = &quot;Not at all nauseated&quot; and at the other end by 7 = &quot;Extremely nauseated.&quot; The outcome variable for the primary analysis was greatest reported nausea from the five day period.</description>
        <time_frame>five days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Patients receive only standard care</description>
          </group>
          <group group_id="O2">
            <title>Expectancy-Neutral Condition</title>
            <description>Handout without expectancy- enhancing component&#xD;
Relaxation MP3 without expectancy-enhancing component&#xD;
Acupressure bands</description>
          </group>
          <group group_id="O3">
            <title>Expectancy-Enhancing Condition</title>
            <description>Handout with expectancy-enhancing component&#xD;
Relaxation MP3 with expectancy-enhancing component&#xD;
Acupressure bands</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Report Nausea Diary</title>
          <description>Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = &quot;Not at all nauseated&quot; and at the other end by 7 = &quot;Extremely nauseated.&quot; The outcome variable for the primary analysis was greatest reported nausea from the five day period.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.87" spread="2.00"/>
                    <measurement group_id="O2" value="3.55" spread="2.00"/>
                    <measurement group_id="O3" value="3.52" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.</non_inferiority_desc>
            <p_value>.05</p_value>
            <p_value_desc>Not adjusted</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.9</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>two months</time_frame>
      <desc>We used a standard definition for adverse events, but because this was a minimal risk study, our IRB required us to report and record only SAEs that were possibly, probably, or definitely related to the study intervention. See Section 5.7.1.1 of the protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm 1</title>
          <description>Patients will receive only standard care</description>
        </group>
        <group group_id="E2">
          <title>Arm 2</title>
          <description>Patients receive:&#xD;
Handout without expectancy- enhancing component&#xD;
Relaxation MP3 without expectancy-enhancing component&#xD;
Acupressure bands</description>
        </group>
        <group group_id="E3">
          <title>Arm 3</title>
          <description>Patients receive:&#xD;
Handout with expectancy- enhancing component&#xD;
Relaxation MP3 with expectancy-enhancing component&#xD;
Acupressure bands</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="76"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="75"/>
              </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>Joseph A. Roscoe, PhD Associate Research Professor</name_or_title>
      <organization>University of Rochester Medical Center</organization>
      <phone>585 275-9962</phone>
      <email>joseph_roscoe@urmc.rochester.edu</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/NCT01695993
org study id: UCCS1202
secondary id: R01AT007474-01A1
nct id: NCT01695993
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who
      expect to have nausea, will be entered. Participants will be randomized to one of three study
      arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure
      bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands.

      Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in
      controlling chemotherapy-induced nausea
Earlier research has shown that the effectiveness of acupressure bands in reducing nausea
      could be enhanced by boosting patients' expectations of the bands' efficacy. The present
      study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized,
      controlled study of 216 breast cancer patients beginning chemotherapy who expect to have
      nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2:
      Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3:
      Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The
      investigators hypothesize that acupressure bands provided with the relaxation MP3 will be
      effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3
      are being examined to determine what is the most effective way to deliver the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Patient Report Nausea Diary
time frame: five days
description: Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The outcome variable for the primary analysis was greatest reported nausea from the five day period.
arm group label: Arm 1 - Standard Care Only
arm group type: No Intervention
description: Patients will receive standard care only
arm group label: Arm 2 - Expectancy-neutral Arm
arm group type: Other
description: Patients receive:
Expectancy-neutral handout
Expectancy-neutral MP3
Acupressure bands
arm group label: Arm 3 - Expectancy-enhancing Arm
arm group type: Experimental
description: Patients receive:
Expectancy-enhancing handout
Expectancy-enhancing MP3
Acupressure bands
intervention type: Device
intervention name: Acupressure bands
description: Bilateral acupressure wrist bands
arm group label: Arm 2 - Expectancy-neutral Arm
arm group label: Arm 3 - Expectancy-enhancing Arm
intervention type: Other
intervention name: Expectancy-neutral handout
description: The expectancy neutral handout has neutral information regarding the acupressure bands
arm group label: Arm 2 - Expectancy-neutral Arm
intervention type: Behavioral
intervention name: Expectancy-neutral MP3
description: Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
arm group label: Arm 2 - Expectancy-neutral Arm
intervention type: Other
intervention name: Expectancy-enhancing handout
description: The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
arm group label: Arm 3 - Expectancy-enhancing Arm
intervention type: Behavioral
intervention name: Expectancy-enhancing MP3
description: Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.
arm group label: Arm 3 - Expectancy-enhancing Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph A Roscoe, Ph.D.
role: Principal Investigator
affiliation: University of Rochester
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Joseph Roscoe
investigator title: Research Associate Professor
mesh term: Nausea
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 