TPS9650 Background: Cancer-related fatigue (CRF) is the most frequently reported symptom associated with cancer and its treatment. Unfortunately, there are limited treatment options to alleviate this distressing symptom. Preliminary data suggest that the combination of exercise, cognitive behavioral therapy (CBT), and methylphenidate (that is, multimodality therapy [MMT]) can play an important role in reducing CRF. The project’s objective is to explore the effects and safety of this MMT on CRF in prostate cancer patients scheduled to receive radiotherapy with androgen deprivation therapy. We hypothesizethat the MMT is capable of reducing CRF as measured by the FACIT-F subscale in prostate cancer patients scheduled to receive radiotherapy. Specific Aims:(1) Our primary aim is to obtain preliminary estimates of the effects of various treatments (exercise, CBT, and methylphenidate) and their combinations in reducing CRF in prostate cancer patients receiving radiotherapy, as measured by the change in patients’ FACIT-F subscale scores taken at baseline and on day 57 and the secondary objective is to determine the effects of the treatments and their combinations on anxiety and depressed mood (both measured by the Hospital Anxiety Depression Scale [HADS]); on physical activity and function (measured by an accelerometer and a handgrip dynamometer, respectively); on levels of inflammatory cytokines (IL-1β, IL-6, TNF-α, and IL-10) in serum and induced monocytes, before and after treatment Methods: For this study, we will use a randomized factorial design to assess 3 treatments (exercise, CBT, and methylphenidate) and their placebos in 8 replications. A total of 32 patients will receive each primary treatment and 32 will not. Patients will be studied for a 57-day period, during which they are scheduled undergo daily radiation treatments with androgen deprivation therapy. Fatigue, anxiety and depressed mood, and inflammatory cytokines will be determined at baseline and at 3 subsequent post-intervention assessments. After successful initiation so far 19/64 patients were enrolled. Accrual continues. Clinical trial information: NCT01410942.
Integrating diet and exercise into care of prostate cancer patients on androgen deprivation therapy
