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

NCT03262831 | Completed

• 1 other identifier: 201708076
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Cancer of Breast

Outcome Measures

Primary Outcomes (3)

• Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled

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

  Completion of study enrollment (estimated to be 6 months)

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

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

  Completion of study enrollment (estimated to be 6 months)

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

  Completion of treatment (estimated to be 6 months)

Secondary Outcomes (4)

• Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)

  Completion of treatment (estimated to be 6 months)

• Effect of yoga exercise as measured by inflammatory markers

  Completion of treatment (estimated to be 6 months)

• Effect of yoga exercise as measured by fatigue index

  Completion of treatment (estimated to be 6 months)

• Effect of yoga exercise as measured by quality of life

  Completion of treatment (estimated to be 6 months)

Study Arms (2)

Arm 1: Yoga

EXPERIMENTAL

* 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.

Other: Yoga; Procedure: Blood draw; Behavioral: FACT-G questionnaire; Procedure: Weight measurement; Behavioral: Recent Physical Activity Questionnaire; Behavioral: NHANES Food Questionnaire

Arm 2: No Yoga

ACTIVE COMPARATOR

-Patients in this arm will not receive a personalized yoga plan

Procedure: Blood draw; Behavioral: FACT-G questionnaire; Procedure: Weight measurement; Behavioral: Recent Physical Activity Questionnaire; Behavioral: NHANES Food Questionnaire

Interventions

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

Arm 1: Yoga

Blood draw PROCEDURE

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

Arm 1: Yoga; Arm 2: No Yoga

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

Arm 1: Yoga; Arm 2: No Yoga

Weight measurement PROCEDURE

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

Arm 1: Yoga; Arm 2: No Yoga

Recent Physical Activity Questionnaire BEHAVIORAL

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

Also known as: RPAQ

Arm 1: Yoga; Arm 2: No Yoga

NHANES Food Questionnaire BEHAVIORAL

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

Arm 1: Yoga; Arm 2: No Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Greaney SK, Amin N, Prudner BC, Compernolle M, Sandell LJ, Tebb SC, Weilbaecher KN, Abeln P, Luo J, Tao Y, Hirbe AC, Peterson LL. Yoga Therapy During Chemotherapy for Early-Stage and Locally Advanced Breast Cancer. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221137285. doi: 10.1177/15347354221137285.

  PMID: 36412916 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga; Blood Specimen Collection; Weights and Measures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lindsay L Peterson, M.D., MSCR

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: January 10, 2018
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)