Clinical trial NCT03262831: Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer
Official title: The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer of Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2017-08-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled
timeFrame: Completion of study enrollment (estimated to be 6 months)
measure: Feasibility of conducting a larger randomized trial using yoga and mindful movement
timeFrame: Completion of study enrollment (estimated to be 6 months)
measure: Efficacy of yoga exercise as measured by weight change from baseline to completion
timeFrame: Completion of treatment (estimated to be 6 months)
Secondary outcomes:
measure: Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)
timeFrame: Completion of treatment (estimated to be 6 months)
measure: Effect of yoga exercise as measured by inflammatory markers
timeFrame: Completion of treatment (estimated to be 6 months)
measure: Effect of yoga exercise as measured by fatigue index
timeFrame: Completion of treatment (estimated to be 6 months)
measure: Effect of yoga exercise as measured by quality of life
timeFrame: Completion of treatment (estimated to be 6 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay L Peterson, M.D., MSCR
role: PRINCIPAL_INVESTIGATOR
References: