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

Primary Purpose

Breast Cancer, Cancer of Breast

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yoga

Blood draw

FACT-G questionnaire

Weight measurement

Recent Physical Activity Questionnaire

NHANES Food Questionnaire

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Yoga

Arm 2: No Yoga

Arm 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.

-Patients in this arm will not receive a personalized yoga plan

Outcomes

Primary Outcome Measures

Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled

-Feasibility is defined as the ability to enroll 60% of eligible patients

Feasibility of conducting a larger randomized trial using yoga and mindful movement

-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

Secondary Outcome Measures

Effect of yoga exercise as measured by rate of pathologic response (partial and complete) (neoadjuvant subset only)

Effect of yoga exercise as measured by inflammatory markers

Effect of yoga exercise as measured by fatigue index

-Fatigue index will be measured by FACT-G questionnaire

Effect of yoga exercise as measured by quality of life

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

Full Information

NCT ID

NCT03262831

First Posted

August 23, 2017

Last Updated

August 29, 2019

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03262831

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

June 26, 2019 (Actual)

Study Completion Date

June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Cancer of Breast

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Yoga

Arm Type

Experimental

Arm Description

Arm Title

Arm 2: No Yoga

Arm Type

Active Comparator

Arm Description

-Patients in this arm will not receive a personalized yoga plan

Intervention Type

Other

Intervention Name(s)

Yoga

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

Baseline and end of treatment To evaluate change in inflammatory markers (CRP, IL-6, and TNF)

Intervention Type

Behavioral

Intervention Name(s)

FACT-G questionnaire

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Weight measurement

Intervention Description

-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment

Intervention Type

Behavioral

Intervention Name(s)

Recent Physical Activity Questionnaire

Other Intervention Name(s)

RPAQ

Intervention Description

-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.

Intervention Type

Behavioral

Intervention Name(s)

NHANES Food Questionnaire

Intervention Description

-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.

Primary Outcome Measure Information:

Title

Feasibility of enrolling patients to larger randomized controlled trial using yoga and mindful movement as measured the number of eligible patients enrolled

Description

-Feasibility is defined as the ability to enroll 60% of eligible patients

Time Frame

Completion of study enrollment (estimated to be 6 months)

Title

Feasibility of conducting a larger randomized trial using yoga and mindful movement

Description

-Feasibility is defined as the ability to have an 80% completion rate of the intervention

Time Frame

Completion of study enrollment (estimated to be 6 months)

Title

Efficacy of yoga exercise as measured by weight change from baseline to completion

Time Frame