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Open Access Highly Accessed Study protocol

A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer

Robert U Newton1*, Dennis R Taaffe2, Nigel Spry34, Robert A Gardiner5, Gregory Levin1, Bradley Wall1, David Joseph34, Suzanne K Chambers6 and Daniel A Galvão1

Author Affiliations

1 Vario Health Institute, Edith Cowan University, Joondalup, WA, Australia

2 School of Human Movement Studies, The University of Queensland, Brisbane, QLD, Australia

3 Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia

4 Faculty of Medicine, University of Western Australia, Nedlands, WA, Australia

5 Centre for Clinical Research at Royal Brisbane Hospital, The University of Queensland, Brisbane, QLD, Australia

6 School of Psychology, Griffith University, Brisbane, QLD, Australia

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BMC Cancer 2009, 9:210  doi:10.1186/1471-2407-9-210

Published: 29 June 2009

Abstract

Background

Androgen deprivation therapy (ADT) is accompanied by a number of adverse side effects including reduced bone mass and increased risk for fracture, reduced lean mass and muscle strength, mood disturbance and increased fat mass compromising physical functioning, independence, and quality of life. The purpose of this investigation is to examine the effects of long term exercise on reversing musculoskeletal-related side effects, and cardiovascular and diabetes risk factors in men receiving androgen deprivation for their prostate cancer. Specifically, we aim to investigate the effects of a 12-month exercise program designed to load the musculoskeletal system and reduce cardiovascular and diabetes disease progression on the following primary endpoints: 1) bone mineral density; 2) cardiorespiratory function and maximal oxygen capacity; 3) body composition (lean mass and fat mass); 4) blood pressure and cardiovascular function; 5) lipids and glycemic control; and 6) quality of life and psychological distress.

Methods/Design

Multi-site randomized controlled trial of 195 men (65 subjects per arm) undergoing treatment for prostate cancer involving ADT in the cities of Perth and Brisbane in Australia. Participants will be randomized to (1) resistance/impact loading exercise, (2) resistance/cardiovascular exercise groups and (3) usual care/delayed exercise. Participants will then undergo progressive training for 12 months. Measurements for primary and secondary endpoints will take place at baseline, 6 and 12 months (end of the intervention).

Discussion

The principal outcome of this project will be the determination of the strength of effect of exercise on the well established musculoskeletal, cardiovascular and insulin metabolism side effects of androgen deprivation in prostate cancer patients. As this project is much longer term than previous investigations in the area of exercise and cancer, we will gain knowledge as to the continuing effects of exercise in this patient population specifically targeting bone density, cardiovascular function, lean and fat mass, physical function and falls risk as primary study endpoints. In terms of advancement of prostate cancer care, we expect dissemination of the knowledge gained from this project to reduce fracture risk, improve physical and functional ability, quality of life and ultimately survival rate in this population.

Clinical Trial Registry

A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer; ACTRN12609000200280