We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727662
First Posted: August 4, 2008
Last Update Posted: April 14, 2015
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.
Information provided by (Responsible Party):
Bower, Julienne, National Center for Complementary and Integrative Health (NCCIH)
July 31, 2008
August 4, 2008
April 14, 2015
June 2008
October 2010   (Final data collection date for primary outcome measure)
Fatigue [ Time Frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention ]
Same as current
Complete list of historical versions of study NCT00727662 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue
Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Cancer
  • Fatigue
  • 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
  • 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
  • Experimental: 1
    Yoga
    Intervention: Other: Iyengar Yoga
  • Active Comparator: 2
    A Wellness Seminar series
    Intervention: Other: Wellness Seminar Series
Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2010
October 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00727662
U01AT003682( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Bower, Julienne, National Center for Complementary and Integrative Health (NCCIH)
National Center for Complementary and Integrative Health (NCCIH)
Not Provided
Principal Investigator: Julienne E Bower, Ph.D. University of California, Los Angeles
National Center for Complementary and Integrative Health (NCCIH)
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP