Yoga Study in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Delayed yoga classes; Behavioral: Yoga

• Registration Number: NCT00476203
• Lead Sponsor: Fred Hutchinson Cancer 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.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-17
• Study First Posted: 2007-05-21
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Delayed yoga classes	Delayed yoga classes (after 6 months) offered \[wait list control group\]
1	Yoga	Immediate yoga classes offered

Primary Outcome Measures

Name	Time	Method
quality of life, fatigue, and body weight	baseline, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
waist and hip circumference	baseline, 6 months, 12 months

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States