Cancer-related fatigue (CRF) is the most frequently reported side effect of cancer and its treatment. Our data and the literature suggest that 60 - 96% of patients experience CRF at some point during their course of treatment. In addition to its profound effect on health-related quality of life (HRQL) and activities of daily living, CRF can promote increased sleep disturbance, difficulties with work-related activities, muscle weakness, and reduction in leisure activity. At present, no extant data support the effectiveness of any specific treatment for CRF. Preliminary data gathered by our research team suggests that Polarity Therapy (PT) is an efficacious non-invasive intervention for alleviating CRF. Fifteen women with CRF receiving radiation therapy for breast cancer who received either standard care, one PT treatment or two PT treatments reported a statistically significant (p < .05) reduction in fatigue after a single PT treatment compared to women receiving standard care. The improvement in fatigue observed with PT was found in 8 of 10 patients receiving PT, with only 1 of 5 patients receiving standard care reporting improvement in fatigue. The current application is for a pilot study that will extend these previous findings by providing preliminary data on the efficacy of PT for reducing CRF, improving HRQL, and improving quality of sleep (QOS) in patients receiving chemotherapy for colorectal cancer. Additionally, this pilot study is designed to refine procedures and methods, provide a sample-size estimate, and aid in the a priori design of mediator and moderator analyses for a planned R01 submission. The current study will utilize a 3-Arm randomized clinical trial design with 60 patients experiencing CRF undergoing adjuvant chemotherapy for colorectal cancer. Arm 1: patients (non-intervention control group) will receive standard clinical care. Arm 2: patients (active control group) will receive standard clinical care plus 2 neck, shoulder and hand massage treatments. Arm 3: patients will receive standard clinical care plus 2 PT treatments. Patients will be studied for a 21-day period encompassing three weekly chemotherapy infusions. Fatigue, HRQL and QOS will be assessed at baseline and at two post-intervention assessments. In addition to a sleep/fatigue diary, actigraphy will be used during the entire 21-day study period to provide objective measures of sleep and fatigue. Anticipated results could have clinical, methodological, and theoretical application in the study and treatment of CRF. ? ?
| Mustian, Karen M; Roscoe, Joseph A; Palesh, Oxana G et al. (2011) Polarity Therapy for cancer-related fatigue in patients with breast cancer receiving radiation therapy: a randomized controlled pilot study. Integr Cancer Ther 10:27-37 |
| Chen, Kevin W; Perlman, Adam; Liao, Jason G et al. (2008) Effects of external qigong therapy on osteoarthritis of the knee. A randomized controlled trial. Clin Rheumatol 27:1497-505 |
