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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727662
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):
Bower, Julienne, National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Fatigue Other: Iyengar Yoga Other: Wellness Seminar Series Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue
Study Start Date : June 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Other: 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.
Other Name: Yoga

Active Comparator: 2
A Wellness Seminar series
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.
Other Name: Health education

Primary Outcome Measures :
  1. Fatigue [ Time Frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention ]

Secondary Outcome Measures :
  1. Secondary outcomes include depressed mood, sleep disturbance, pain, quality of life, and proinflammatory cytokine activity [ Time Frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727662

United States, California
University of California, Cousins Center for PNI
Los Angeles, California, United States, 90095
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Julienne E Bower, Ph.D. University of California, Los Angeles

Responsible Party: Bower, Julienne, Assistant Professor, National Center for Complementary and Integrative Health (NCCIH) Identifier: NCT00727662     History of Changes
Other Study ID Numbers: U01AT003682 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Bower, Julienne, National Center for Complementary and Integrative Health (NCCIH):
Breast Cancer
Proinflammatory Cytokines
Physical functioning
Quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms