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Yoga Study in Breast Cancer Patients (Yoga)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00476203
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : November 28, 2012
National Institutes of Health (NIH)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Yoga Other: Delayed yoga classes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
Study Start Date : May 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Immediate yoga classes offered
Behavioral: Yoga
Instructor-led yoga classes 1/time per week + 4 days of home practice

Delayed yoga classes (after 6 months) offered [wait list control group]
Other: Delayed yoga classes
Delayed yoga classes (after 6 months) offered [wait list control group]

Primary Outcome Measures :
  1. quality of life, fatigue, and body weight [ Time Frame: baseline, 6 months, 12 months ]

Secondary Outcome Measures :
  1. waist and hip circumference [ Time Frame: baseline, 6 months, 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476203

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Institutes of Health (NIH)
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Study Director: Alyson Littman, PhD Department of Epidemiology, UW
Principal Investigator: Anne McTiernan, MD, PhD Fred Hutchinson Cancer Research Center

Additional Information:
Publications of Results:
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Responsible Party: Mark Boyer, Director of Sponsored Research, Fred Hutchinson Cancer Research Center Identifier: NCT00476203     History of Changes
Other Study ID Numbers: PHS - 6434
U54CA116847-01 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Fred Hutchinson Cancer Research Center:
Breast Cancer
Quality of Life

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases