<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/NCT03262831</url>
  </required_header>
  <id_info>
    <org_study_id>201708076</org_study_id>
    <nct_id>NCT03262831</nct_id>
  </id_info>
  <brief_title>Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer</brief_title>
  <official_title>The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Foundation for Barnes-Jewish Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators hypothesize that a personalized yoga program with mindful movement&#xD;
      implemented during breast cancer therapy will benefit women in multiple ways. The&#xD;
      investigators predict that women participating in the program will experience less weight&#xD;
      gain and fatigue and will have an improved quality of life compared to women not&#xD;
      participating in the program. The investigators predict that this will be associated with&#xD;
      decreased markers of inflammation. The investigators will also evaluate whether there is&#xD;
      improved pathologic response rate compared to historical controls. This study will provide&#xD;
      pilot data for a larger randomized controlled trial assessing whether program can provide&#xD;
      long-term improvement in quality of life, weight maintenance, and the serum and tumor changes&#xD;
      correlating with a reduced risk of recurrence and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled</measure>
    <time_frame>Completion of study enrollment (estimated to be 6 months)</time_frame>
    <description>-Feasibility is defined as the ability to enroll 60% of eligible patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of conducting a larger randomized trial using yoga and mindful movement</measure>
    <time_frame>Completion of study enrollment (estimated to be 6 months)</time_frame>
    <description>-Feasibility is defined as the ability to have an 80% completion rate of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of yoga exercise as measured by weight change from baseline to completion</measure>
    <time_frame>Completion of treatment (estimated to be 6 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)</measure>
    <time_frame>Completion of treatment (estimated to be 6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of yoga exercise as measured by inflammatory markers</measure>
    <time_frame>Completion of treatment (estimated to be 6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of yoga exercise as measured by fatigue index</measure>
    <time_frame>Completion of treatment (estimated to be 6 months)</time_frame>
    <description>-Fatigue index will be measured by FACT-G questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of yoga exercise as measured by quality of life</measure>
    <time_frame>Completion of treatment (estimated to be 6 months)</time_frame>
    <description>-Quality of life will be measured by FACT-G questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Cancer of Breast</condition>
  <arm_group>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga&#xD;
Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.&#xD;
The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel&#xD;
During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: No Yoga</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>-Patients in this arm will not receive a personalized yoga plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax</description>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Baseline and end of treatment&#xD;
To evaluate change in inflammatory markers (CRP, IL-6, and TNF)</description>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
    <arm_group_label>Arm 2: No Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FACT-G questionnaire</intervention_name>
    <description>7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days&#xD;
Answers range from 0=not at all to 4=very much</description>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
    <arm_group_label>Arm 2: No Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Weight measurement</intervention_name>
    <description>-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment</description>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
    <arm_group_label>Arm 2: No Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recent Physical Activity Questionnaire</intervention_name>
    <description>-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.</description>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
    <arm_group_label>Arm 2: No Yoga</arm_group_label>
    <other_name>RPAQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NHANES Food Questionnaire</intervention_name>
    <description>-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.</description>
    <arm_group_label>Arm 1: Yoga</arm_group_label>
    <arm_group_label>Arm 2: No Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Critera:&#xD;
&#xD;
          -  Age ≥ 18.&#xD;
&#xD;
          -  Female.&#xD;
&#xD;
          -  Newly diagnosed with Stage I-III breast cancer.&#xD;
&#xD;
          -  Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine&#xD;
             therapy.&#xD;
&#xD;
          -  Not currently regularly practicing yoga (defined as at least once a month).&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
             document&#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>Lindsay L Peterson, M.D., MSCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03262831
org study id: 201708076
nct id: NCT03262831
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that a personalized yoga program with mindful movement
      implemented during breast cancer therapy will benefit women in multiple ways. The
      investigators predict that women participating in the program will experience less weight
      gain and fatigue and will have an improved quality of life compared to women not
      participating in the program. The investigators predict that this will be associated with
      decreased markers of inflammation. The investigators will also evaluate whether there is
      improved pathologic response rate compared to historical controls. This study will provide
      pilot data for a larger randomized controlled trial assessing whether program can provide
      long-term improvement in quality of life, weight maintenance, and the serum and tumor changes
      correlating with a reduced risk of recurrence and mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled
time frame: Completion of study enrollment (estimated to be 6 months)
description: -Feasibility is defined as the ability to enroll 60% of eligible patients
measure: Feasibility of conducting a larger randomized trial using yoga and mindful movement
time frame: Completion of study enrollment (estimated to be 6 months)
description: -Feasibility is defined as the ability to have an 80% completion rate of the intervention
measure: Efficacy of yoga exercise as measured by weight change from baseline to completion
time frame: Completion of treatment (estimated to be 6 months)
measure: Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)
time frame: Completion of treatment (estimated to be 6 months)
measure: Effect of yoga exercise as measured by inflammatory markers
time frame: Completion of treatment (estimated to be 6 months)
measure: Effect of yoga exercise as measured by fatigue index
time frame: Completion of treatment (estimated to be 6 months)
description: -Fatigue index will be measured by FACT-G questionnaire
measure: Effect of yoga exercise as measured by quality of life
time frame: Completion of treatment (estimated to be 6 months)
description: -Quality of life will be measured by FACT-G questionnaire
arm group label: Arm 1: Yoga
arm group type: Experimental
description: Prior to start of treatment, a yoga therapist will work with each patient to develop a personalized yoga protocol using Gentle Hatha and Restorative Yoga
Each protocol will consist of 5-10 minutes of centering poses to invite focus and relaxation, then 15-20 minutes of seated and standing active poses, ending with 5-10 minutes of guided relaxation.
The personalized practice will be given to each participant and she will be asked to practice beginning at the start of neoadjuvant treatment at least 3 times a week (but preferably daily) at home for at least 30 minutes each time. Participants will continue their personalized yoga practice during the entirety of treatment. Each participant will be asked to journal when and for how long she practices at home and make any comments as to how the practice might have made her feel
During participation, weekly follow-up calls will be made by a member of the study team to each participant randomized to the yoga arm.
arm group label: Arm 2: No Yoga
arm group type: Active Comparator
description: -Patients in this arm will not receive a personalized yoga plan
intervention type: Other
intervention name: Yoga
description: The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax
arm group label: Arm 1: Yoga
intervention type: Procedure
intervention name: Blood draw
description: Baseline and end of treatment
To evaluate change in inflammatory markers (CRP, IL-6, and TNF)
arm group label: Arm 1: Yoga
arm group label: Arm 2: No Yoga
intervention type: Behavioral
intervention name: FACT-G questionnaire
description: 7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days
Answers range from 0=not at all to 4=very much
arm group label: Arm 1: Yoga
arm group label: Arm 2: No Yoga
intervention type: Procedure
intervention name: Weight measurement
description: -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
arm group label: Arm 1: Yoga
arm group label: Arm 2: No Yoga
intervention type: Behavioral
intervention name: Recent Physical Activity Questionnaire
description: -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
arm group label: Arm 1: Yoga
arm group label: Arm 2: No Yoga
other name: RPAQ
intervention type: Behavioral
intervention name: NHANES Food Questionnaire
description: -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
arm group label: Arm 1: Yoga
arm group label: Arm 2: No Yoga
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lindsay L Peterson, M.D., MSCR
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No