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OpenTrials
Completed

NCT Number: NCT03262831

Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer of Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Critera:

  • Age ≥ 18.
  • Female.
  • Newly diagnosed with Stage I-III breast cancer.
  • Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy.
  • Not currently regularly practicing yoga (defined as at least once a month).
  • Able to read and understand English
  • Able to understand and willing to sign an IRB-approved written informed consent document

Treatment and study plan

yoga

Other

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

Blood draw

Procedure
  • Baseline and end of treatment
  • To evaluate change in inflammatory markers (CRP, IL-6, and TNF)

FACT-G questionnaire

Behavioral
  • 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

Weight measurement

Procedure

-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment

Recent Physical Activity Questionnaire

Behavioral

-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.

Other names: RPAQ

NHANES Food Questionnaire

Behavioral

-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

Primary outcomes

  1. 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)

    -Feasibility is defined as the ability to enroll 60% of eligible patients

  2. Feasibility of conducting a larger randomized trial using yoga and mindful movement

    Time frame: Completion of study enrollment (estimated to be 6 months)

    -Feasibility is defined as the ability to have an 80% completion rate of the intervention

  3. Efficacy of yoga exercise as measured by weight change from baseline to completion

    Time frame: Completion of treatment (estimated to be 6 months)

Secondary outcomes

  1. 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)

  2. Effect of yoga exercise as measured by inflammatory markers

    Time frame: Completion of treatment (estimated to be 6 months)

  3. Effect of yoga exercise as measured by fatigue index

    Time frame: Completion of treatment (estimated to be 6 months)

    -Fatigue index will be measured by FACT-G questionnaire

  4. Effect of yoga exercise as measured by quality of life

    Time frame: Completion of treatment (estimated to be 6 months)

    -Quality of life will be measured by FACT-G questionnaire

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital

Registry information

Official study title

The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2017
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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