A study of complementary therapies in men receiving radiation therapy for prostate cancer: A randomized feasibility trial

Abstract

15638 Background: Prostate-cancer patients suffer from substantial distress with both their diagnosis and treatment. Several studies have looked at the use of complementary and alternative medicine (CAM) in patients with prostate cancer to alleviate their stress and effects of therapy. We elected to study Reiki and Relaxation Response Therapy (RRT) in prostate-cancer patients. Methods: Patients receiving an eight-week course of radiation for prostate cancer were eligible. Consented participants were randomly assigned to RRT, to Reiki, or to no CAM therapy during radiotherapy. Reiki was given twice weekly, RRT once weekly. The feasibility of enrolling 60 patients, their compliance with physiologic and psychological testing, and preliminary assessment of the effect of CAM are the study endpoints. Statistical analysis of feasibility is based on the assumption that at least 80% of patients would complete 14/16 Reiki sessions or 7/8 RRT sessions. Patients were tested for outcome measures at baseline, at randomization, halfway through radiation, at completion of radiation and 2 months later. The psychosocial outcome measures used were the STAI, CES-D, FACT-G, FACIT: Fatigue Scale, and EPIC: Hormone Section. Physiological assessment included salivary cortisol, blood samples for interleukin-6, tumor necrosis factor alpha, CD8, natural killer cells, heat shock protein 70 and a validated bowel-and-bladder-symptom questionnaire. Results: We have enrolled 62 of 108 eligible patients (60%) within 18 months. The number of enrollment has been increased to 62 as two patients changed their treatment location. To date five patients dropped out short of completion, 1 became ineligible, 32 have completed the study, 20 are still receiving CAM therapy or are in active follow-up and 2 are awaiting randomization and radiotherapy. Conclusions: Complementary therapy appears to be of much interest to prostate-cancer patients. At the completion of the trial, we will have more data on feasibility, compliance and preliminary results on the effect of CAM intervention in this population. No significant financial relationships to disclose.