Status:
COMPLETED
A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Breast Cancer
Fatigue
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 f...
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 disrupti...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00727662
Start Date
June 1 2008
End Date
December 1 2010
Last Update
April 14 2015
Active Locations (1)
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1
University of California, Cousins Center for PNI
Los Angeles, California, United States, 90095