Breast Cancer, Cancer of Breast
Conditions
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.
Interventions
OTHERYoga
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
PROCEDUREBlood draw
* Baseline and end of treatment * To evaluate change in inflammatory markers (CRP, IL-6, and TNF)
BEHAVIORALFACT-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
PROCEDUREWeight measurement
-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
BEHAVIORALRecent Physical Activity Questionnaire
-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
BEHAVIORALNHANES Food Questionnaire
-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
Sponsors
The Foundation for Barnes-Jewish Hospital
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Efficacy of yoga exercise as measured by weight change from baseline to completion | Completion of treatment (estimated to be 6 months) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 quality of life | Completion of treatment (estimated to be 6 months) | -Quality of life will be measured by FACT-G questionnaire |
| 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) | -Fatigue index will be measured by FACT-G questionnaire |
Countries
United States
Outcome results
None listed