|No phase specified||Biomarker/Laboratory analysis, Supportive care||Completed||21 and over||NCI, Other||OSU-06137|
NCI-2012-00564, R01 CA126857, OSU-2007C0004, 2007C0004, NCT00486525
RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.
PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
Further Study Information
- To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors.
OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.
- Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .
- Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.
- Stage 0-IIIA breast cancer survivor
- Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)
- At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last
- Women who are not currently practicing yoga and have not participated in any of the following activities:
- Meditation, tai chi, or related activities
- Yoga or tai chi within the past 6 months
- Had classes for or practiced yoga for more than 3 months
- Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible
- No inflammatory breast cancer
- Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
- Physically able to fully participate in yoga intervention
- Inability to comfortably get up and down from the floor 2-3 times in a session
- Breathing problems requiring use of oxygen
- Problems walking without a cane or walker assistance
- Prior knee or hip replacement with limited movement in the joint
- Inability to comfortably lie on the stomach
- Alcohol, or drug abuse
- Diagnosis of any of the following conditions:
- Chronic obstructive pulmonary disease
- Uncontrolled hypertension
- Evidence of liver or kidney failure
- Symptomatic ischemic heart disease
- Significant visual or auditory problems
- Mental disorder or cognitive impairment
- Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
- Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis
- History of breast or any other cancer, except basal or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No regular use of medications with major immunological consequences (e.g., steroids)
Trial Lead Organizations/Sponsors
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterNational Cancer Institute
|Janice Kiecolt-Glaser||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00486525
ClinicalTrials.gov processed this data on April 10, 2014
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