Multimodal therapy for the treatment of fatigue in patients with prostate cancer receiving androgen deprivation therapy and radiation.

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.

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EXCAP exercise to improve fatigue, cardiopulmonary function, and strength: A phase II RCT among older prostate cancer patients receiving radiation and androgen deprivation therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9010 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9010-9010

Author(s):

Karen Michelle Mustian ◽

Lisa Sprod ◽

Michelle Christine Janelsins ◽

Luke Joseph Peppone ◽

Supriya Gupta Mohile ◽

...

Keyword(s):

Prostate Cancer ◽

Cancer Patients ◽

Androgen Deprivation Therapy ◽

Background Radiation ◽

Androgen Deprivation ◽

Self Report ◽

Phase Iii ◽

Vo2 Max ◽

Post Intervention ◽

Cardiopulmonary Function

9010 Background: Radiation therapy (RT) and androgen deprivation therapy (ADT) result in cancer-related fatigue (CRF), decreased cardiopulmonary function (CPF) and decreased strength. Research suggests exercise can improve CRF during RT and ADT, through physical conditioning responses that improve CPF and strength. We explored the influence of an individually-tailored, home-based exercise intervention (EXCAP), including progressive resistance and aerobic training, on CRF, CPF and strength. Methods: Older prostate cancer patients (N=58; mean age=67), receiving RT (47%) or ADT (53%), were randomized to 6 wks of EXCAP (7 days/wk) or standard care (RT or ADT with no exercise). CPF (VO2 max) was assessed via graded exercise testing (GXT) or a 6-minute walk test when GXT was contraindicated. Muscular strength was assessed using multiple repetition maximum testing (chest press and leg extension). CRF was assessed via valid self-report questionnaires (BFI, POMS-FI, MFSI). All assessments were pre- and post-intervention. Results: ANCOVAs, controlling for baseline, revealed significant differences between groups in mean levels of CRF on the BFI and POMS-FI (all p<0.05), and a trend toward differences on the MFSI (p<0.10) with significant baseline interactions (all p<0.05) post-intervention: exercisers decreased CRF while controls increased. ANCOVAs revealed a trend toward differences between groups in mean levels of CPF (VO2 max) and strength (all p<0.10): exercisers improved while controls declined in performance. Pearson correlations revealed significant inverse associations between changes in CRF (BFI) and CPF (p<0.05;r=-0.0.36), and CRF and strength (p<0.05;r=-0.0.31). MANOVA revealed that changes in CPF and strength significantly predicted changes in CRF (p<0.05, r=0.67) and accounted for 45% of the variance. Conclusions: Exercise improves CRF and these improvements may be mediated, in part, by improvements in CPF and strength. Future phase III RCTs with prostate cancer patients receiving RT and ADT are needed to confirm these relationships. Funding: DOD W81XWH-07-1-0341, NCI K07CA120025, NCI 1R25CA102618.

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