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Yoga Study in Breast Cancer Patients

NCT ID: NCT00476203

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-05-31

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.

Conditions

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Breast Cancer

Keywords

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Breast Cancer Yoga Quality of Life Obesity Fatigue Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Immediate yoga classes offered

Group Type EXPERIMENTAL

Yoga

Intervention Type BEHAVIORAL

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

2

Delayed yoga classes (after 6 months) offered \[wait list control group\]

Group Type OTHER

Delayed yoga classes

Intervention Type OTHER

Delayed yoga classes (after 6 months) offered \[wait list control group\]

Interventions

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Yoga

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

Intervention Type BEHAVIORAL

Delayed yoga classes

Delayed yoga classes (after 6 months) offered \[wait list control group\]

Intervention Type OTHER

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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Alyson Littman, PhD

Role: STUDY_DIRECTOR

Department of Epidemiology, UW

Anne McTiernan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21207071 (View on PubMed)

Other Identifiers

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U54CA116847-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PHS - 6434

Identifier Type: -

Identifier Source: org_study_id