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

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer of Breast

• Registration Number: NCT03262831
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2018-01-10
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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
Efficacy of yoga exercise as measured by weight change from baseline to completion	Completion of treatment (estimated to be 6 months)

Secondary Outcome Measures

Name	Time	Method
Effect of yoga exercise as measured by inflammatory markers	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 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 fatigue index	Completion of treatment (estimated to be 6 months)	-Fatigue index will be measured by FACT-G questionnaire

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States