Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- National Cancer Institute
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00486525
ClinicalTrials.gov processed this data on February 27, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.