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

The Washington University

Status

Completed

Conditions

Cancer of Breast

Breast Cancer

Treatments

Procedure: Blood draw

Behavioral: Recent Physical Activity Questionnaire

Procedure: Weight measurement

Other: Yoga

Behavioral: NHANES Food Questionnaire

Behavioral: FACT-G questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT03262831

201708076

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Arm 1: Yoga

Experimental group

Description:

* 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.

Treatment: