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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03262831
• Collaborator: The Foundation for Barnes-Jewish Hospital (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Cancer of Breast	Other: Yoga; Procedure: Blood draw; Behavioral: FACT-G questionnaire; Procedure: Weight measurement; Behavioral: Recent Physical Activity Questionnaire; Behavioral: NHANES Food Questionnaire	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer
• Actual Study Start Date: Jan 10, 2018
• Actual Primary Completion Date: Jun 26, 2019
• Actual Study Completion Date: Jun 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Yoga 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; 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; Procedure: Blood draw; Baseline and end of treatment To evaluate change in inflammatory markers (CRP, IL-6, and TNF); Behavioral: FACT-G questionnaire; 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; Procedure: Weight measurement; -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment; Behavioral: Recent Physical Activity Questionnaire; -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.; Other Names: RPAQ ; Behavioral: NHANES Food Questionnaire; -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
Active Comparator: Arm 2: No Yoga -Patients in this arm will not receive a personalized yoga plan	Procedure: Blood draw; Baseline and end of treatment To evaluate change in inflammatory markers (CRP, IL-6, and TNF); Behavioral: FACT-G questionnaire; 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; Procedure: Weight measurement; -Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment; Behavioral: Recent Physical Activity Questionnaire; -To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.; Other Names: RPAQ ; Behavioral: NHANES Food Questionnaire; -To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

Outcome Measures

Primary Outcome Measures

1. Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled [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 [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 [Completion of treatment (estimated to be 6 months)]

Secondary Outcome Measures

1. 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)]

2. Effect of yoga exercise as measured by inflammatory markers [Completion of treatment (estimated to be 6 months)]

3. Effect of yoga exercise as measured by fatigue index [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 [Completion of treatment (estimated to be 6 months)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Lindsay L Peterson, M.D., MSCR, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03262831
• Other Study ID Numbers: 201708076
• First Posted: Aug 25, 2017
• Last Update Posted: Sep 3, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 3, 2019