Clinical trial NCT00476203: Yoga Study in Breast Cancer Patients
Official title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Yoga
Quality of Life
Obesity
Fatigue
Weight
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-05-21
Enrollment: 63
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: quality of life, fatigue, and body weight
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: waist and hip circumference
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Department of Epidemiology, UW
name: Alyson Littman, PhD
role: STUDY_DIRECTOR
affiliation: Fred Hutchinson Cancer Center
name: Anne McTiernan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.