A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue

NCT ID: NCT00727662

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-12-31

Brief Summary

This randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible and acceptable to breast cancer survivors with minimal side effects and that the Yoga intervention will be effective in improving fatigue and physical performance.

Detailed Description

Fatigue is the most common and distressing side effect of cancer treatment and persists beyond successful treatment completion in approximately 30% of breast cancer survivors, causing serious disruption in quality of life. Behavioral interventions incorporating physical activity or relaxation/stress management have demonstrated beneficial effects on cancer-related fatigue, although research in cancer survivors is limited. Mind-body interventions such as yoga are extremely popular among cancer patients and offer a promising alternative to traditional treatments. Research is needed to establish the feasibility and efficacy of these interventions in cancer populations, particularly those who are experiencing problems with fatigue.

Conditions

Breast Cancer; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Yoga

Group Type: EXPERIMENTAL

Iyengar Yoga

Intervention Type: OTHER

The poses and breathing techniques to be used in this study are based on sequences developed by B.K.S. Iyengar for breast cancer survivors who suffer from fatigue. Women will start with simple versions of the poses and progress to more advanced versions over the course of the intervention.

2

A Wellness Seminar series

Group Type: ACTIVE_COMPARATOR

Wellness Seminar Series

Intervention Type: OTHER

The Wellness Seminar Series consists of lectures on key topics, followed by group discussion. This series will focus entirely on cancer survivorship, including sessions on quality of life, side effects of cancer treatment, stress, nutrition and psychosocial issues.

Interventions

Iyengar Yoga

The poses and breathing techniques to be used in this study are based on sequences developed by B.K.S. Iyengar for breast cancer survivors who suffer from fatigue. Women will start with simple versions of the poses and progress to more advanced versions over the course of the intervention.

Intervention Type: OTHER

Wellness Seminar Series

The Wellness Seminar Series consists of lectures on key topics, followed by group discussion. This series will focus entirely on cancer survivorship, including sessions on quality of life, side effects of cancer treatment, stress, nutrition and psychosocial issues.

Intervention Type: OTHER

Other Intervention Names

Yoga; Health education

Eligibility Criteria

Inclusion Criteria

• Diagnosed with early, resectable breast cancer (Stage I or II)
• Completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously
• No other cancer in last 5 years, including breast cancer recurrence
• Postmenopausal women
• Age 40 - 65
• Reporting persistent cancer-related fatigue

Exclusion Criteria

• Evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit < 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)
• Evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)
• Physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)
• Regular use of medications and/or behavioral therapies that would confound evaluation of IY, including regular participation in yoga classes
• Presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)
• Use of medications that might confound immune evaluation (e.g., regular use of corticosteroids, narcotics, opiates)
• Unable to commit to intervention schedule
• Body mass index greater than 30 kg/m2
• Regular tobacco (defined as daily or near daily) or alcohol use (defined as > 2 drinks/day)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Responsible Party

Bower, Julienne

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julienne E Bower, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Cousins Center for PNI

Los Angeles, California, United States

Countries

United States

References

Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. doi: 10.1177/107327480501200304.

Reference Type: BACKGROUND

PMID: 16062164 (View on PubMed)

Other Identifiers

U01AT003682

Identifier Type: NIH

Identifier Source: org_study_id

View Link