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Yoga Study in Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00476203
First received: May 17, 2007
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Behavioral: Yoga
Other: Delayed yoga classes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • quality of life, fatigue, and body weight [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • waist and hip circumference [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: May 2007
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Immediate yoga classes offered
 Behavioral: Yoga
Instructor-led yoga classes 1/time per week + 4 days of home practice
2
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]

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476203

Locations
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)
Investigators
Study Director: Alyson Littman, PhD Department of Epidemiology, UW
Principal Investigator: Anne McTiernan, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Yoga for breast cancer patients study home page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Mark Boyer, Director of Sponsored Research, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00476203     History of Changes
Other Study ID Numbers: PHS - 6434, U54 CA116847-01
Study First Received: May 17, 2007
Last Updated: November 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
Breast Cancer
Yoga
Quality of Life
 Obesity
Fatigue
Weight

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

ClinicalTrials.gov processed this record on May 23, 2013