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Open Access Study protocol

Can exercise ameliorate treatment toxicity during the initial phase of testosterone deprivation in prostate cancer patients? Is this more effective than delayed rehabilitation?

Robert U Newton1*, Dennis R Taaffe123, Nigel Spry145, Prue Cormie1, Suzanne K Chambers16, Robert A Gardiner17, David HK Shum6, David Joseph145 and Daniel A Galvão1

Author affiliations

1 Edith Cowan University Health and Wellness Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup, Western Australia 6027, Australia

2 School of Environmental and Life Sciences, The University of Newcastle, Newcastle, NSW, Australia

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

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

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

6 Behavioural Basis of Health Program, Griffith Health Institute, Griffith University, Brisbane, QLD, Australia

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

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Citation and License

BMC Cancer 2012, 12:432  doi:10.1186/1471-2407-12-432

Published: 26 September 2012

Abstract

Background

There has been substantial increase in use of androgen deprivation therapy as adjuvant management of prostate cancer. However, this leads to a range of musculoskeletal toxicities including reduced bone mass and increased skeletal fractures compounded with rapid metabolic alterations, including increased body fat, reduced lean mass, insulin resistance and negative lipoprotein profile, increased incidence of cardiovascular and metabolic morbidity, greater distress and reduced quality of life. Numerous research studies have demonstrated certain exercise prescriptions to be effective at preventing or even reversing these treatment toxicities. However, all interventions to date have been of rehabilitative intent being implemented after a minimum of 3 months since initiation of androgen deprivation, by which time considerable physical and psychological health problems have manifested. The pressing question is whether it is more efficacious to commence exercise therapy at the same time as initiating androgen deprivation, so treatment induced adverse effects can be immediately attenuated or indeed prevented.

Methods/design

We are proposing a multi-site randomized controlled trial with partial crossover to examine the effects of timing of exercise implementation (immediate or delayed) on preserving long-term skeletal health, reversing short- and long-term metabolic and cardiovascular risk factors, and supporting mental health in men receiving androgen deprivation therapy. 124 men who are about to initiate androgen deprivation for prostate cancer will be randomized to immediate or delayed groups. Immediate will commence a 6-month exercise program within 7–10 days of their first dose. Delayed will receive usual care for 6 months and then commence the exercise program for 6 months (partial cross-over). Immediate will be free to adopt the lifestyle of their choosing following the initial 6-month intervention. Measurements for primary and secondary endpoints will take place at baseline, 6 months and 12 months.

Discussion

This project is unique as it explores a fundamental question of when exercise implementation will be of most benefit and addresses both physical and psychological consequences of androgen deprivation initiation. The final outcome may be adjunct treatment which will reduce if not prevent the toxicities of androgen deprivation, ultimately resulting in reduced morbidity and mortality for men with prostate cancer.

Trial registration

ACTRN12612000097842

Keywords:
Prostate cancer; Androgen deprivation therapy; Exercise; Resistance training; Aerobic training; Side-effects