N/A
Completed N=200
Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
Source: ClinicalTrials.gov NCT00486525 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Stimulated ln (TNF-a) — 8.31; 8.39; 8.31; 8.44 ln (pg/mL) — p=0.20
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stimulated ln (TNF-a) |
8.31; 8.39; 8.31; 8.44 | 0.20 |
| PRIMARY Stimulated ln (IL-6) |
9.68; 9.76; 9.69; 9.85 | 0.2 |
| PRIMARY Stimulated ln (IL-1b) |
8.31; 8.42; 8.32; 8.55 | 0.33 |
| PRIMARY MFSI-SF Fatigue |
6.1; 10.3; 5.4; 12.4 | 0.058 |
| PRIMARY Vitality, SF-36 |
58.7; 52.3; 58.1; 51.6 | 0.01 sig |
| PRIMARY CES-D |
8.1; 9.2; 8.5; 9.7 | 0.28 |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Inclusion criteria
- 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
Exclusion criteria
- 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:
- Diabetes
- 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)
Data sourced from ClinicalTrials.gov (NCT00486525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.