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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00727662
First received: July 31, 2008
Last updated: August 23, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention
Breast Cancer
Fatigue
 Other: Iyengar Yoga
Other: Wellness Seminar Series

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Fatigue [ Time Frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Yoga
 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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727662

Locations
United States, California
University of California, Cousins Center for PNI
Los Angeles, California, United States, 90095
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Julienne E Bower, Ph.D. University of California, Los Angeles
  More Information

Publications:

Responsible Party: Julienne E. Bower, Ph.D., Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00727662     History of Changes
Other Study ID Numbers: U01 AT003682
Study First Received: July 31, 2008
Last Updated: August 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Breast Cancer
Fatigue
Proinflammatory Cytokines
Physical functioning
Quality of life

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

ClinicalTrials.gov processed this record on May 21, 2013