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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262831
• Other study ID #: 201708076
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: June 26, 2019

Study information

• Verified date: August 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of Breast

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	BJH Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion of study enrollment (estimated to be 6 months)
Primary	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	Completion of study enrollment (estimated to be 6 months)
Primary	Efficacy of yoga exercise as measured by weight change from baseline to completion		Completion of treatment (estimated to be 6 months)
Secondary	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)
Secondary	Effect of yoga exercise as measured by inflammatory markers		Completion of treatment (estimated to be 6 months)
Secondary	Effect of yoga exercise as measured by fatigue index	-Fatigue index will be measured by FACT-G questionnaire	Completion of treatment (estimated to be 6 months)
Secondary	Effect of yoga exercise as measured by quality of life	-Quality of life will be measured by FACT-G questionnaire	Completion of treatment (estimated to be 6 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine