Yoga Study in Breast Cancer Patients

Breast Cancer Clinical Trial

— Yoga  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476203
• Other study ID #: PHS - 6434
• Secondary ID: U54CA116847-01
• Status: Completed
• Phase: N/A
• First received: May 17, 2007
• Last updated: November 27, 2012
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Yoga
Instructor-led yoga classes 1/time per week + 4 days of home practice

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

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life, fatigue, and body weight		baseline, 6 months, 12 months	No
Secondary	waist and hip circumference		baseline, 6 months, 12 months	No

External Links

•   Yoga for breast cancer patients study home page