Back to resultsA Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue
Primary Purpose
Breast Cancer, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iyengar Yoga
Wellness Seminar Series
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Fatigue, Proinflammatory Cytokines, Physical functioning, Quality of life
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)
Sites / Locations
- University of California, Cousins Center for PNI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Yoga
A Wellness Seminar series
Outcomes
Primary Outcome Measures
Fatigue
Secondary Outcome Measures
Secondary outcomes include depressed mood, sleep disturbance, pain, quality of life, and proinflammatory cytokine activity
Full Information
NCT ID
NCT00727662
First Posted
July 31, 2008
Last Updated
April 13, 2015
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00727662
Brief Title
A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue
Official Title
Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue
Keywords
Breast Cancer, Fatigue, Proinflammatory Cytokines, Physical functioning, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Yoga
Arm Title
2
Arm Type
Active Comparator
Arm Description
A Wellness Seminar series
Intervention Type
Other
Intervention Name(s)
Iyengar Yoga
Other Intervention Name(s)
Yoga
Intervention Description
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
Intervention Name(s)
Wellness Seminar Series
Other Intervention Name(s)
Health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue
Time Frame
Measured at baseline, after the 12 week intervention and at 3 months post-intervention
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julienne E Bower, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Cousins Center for PNI
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16062164
Citation
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.
Results Reference
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A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue
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