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

NCT03262831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Yoga

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

PROCEDURE

Blood draw

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

BEHAVIORAL

FACT-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

PROCEDURE

Weight measurement

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

BEHAVIORAL

Recent Physical Activity Questionnaire

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

BEHAVIORAL

NHANES Food Questionnaire

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

Sponsors & Collaborators

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Lindsay L Peterson, M.D., MSCR · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2019-06-26
Completion
2019-06-26

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262831 on ClinicalTrials.gov