Yoga Study in Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Yoga
* Other: Delayed yoga classes


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Immediate yoga classes offered | Behavioral: Yoga<br>* Instructor-led yoga classes 1/time per week + 4 days of home practice<br>|
| Other: 2<br>Delayed yoga classes (after 6 months) offered [wait list control group] | Other: Delayed yoga classes<br>* Delayed yoga classes (after 6 months) offered [wait list control group]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life, fatigue, and body weight |  | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist and hip circumference |  | baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Yoga, Quality of Life, Obesity, Fatigue, Weight