Yoga Study in Breast Cancer Patients (Yoga)
November 27, 2012 updated by: Fred Hutchinson Cancer Center
Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Women who are overweight or obese have a higher risk of breast cancer than normal weight women.
Furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women.
Yoga has been associated with reduced weight gain and weight loss in persons without cancer.
However, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients.
Both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice.
The specific aims of the proposed trial are to examine, in women with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Age 21-75
- Diagnosed with a primary breast cancer Stage 0-IIIa
- Current tamoxifen or aromatase inhibitor use is allowed
- At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
- BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater)
- No contraindications to participating in a yoga program
- Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English
- Gives informed consent, agrees to be randomly assigned
Exclusion Criteria:
- Plans to leave the study area within the follow-up period
- Is pregnant or plans to become pregnant during the study period.
- History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
- Has practiced yoga more than 1 time per month in the past six months.
- Current use of medications likely to interfere with adherence to interventions or study outcomes
- Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Immediate yoga classes offered
|
Instructor-led yoga classes 1/time per week + 4 days of home practice
|
|
Other: 2
Delayed yoga classes (after 6 months) offered [wait list control group]
|
Delayed yoga classes (after 6 months) offered [wait list control group]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
quality of life, fatigue, and body weight
Time Frame: baseline, 6 months, 12 months
|
baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
waist and hip circumference
Time Frame: baseline, 6 months, 12 months
|
baseline, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Alyson Littman, PhD, Department of Epidemiology, UW
- Principal Investigator: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
May 17, 2007
First Submitted That Met QC Criteria
May 17, 2007
First Posted (Estimate)
May 21, 2007
Study Record Updates
Last Update Posted (Estimate)
November 28, 2012
Last Update Submitted That Met QC Criteria
November 27, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHS - 6434
- U54CA116847-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.