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Open Access Study protocol

A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy

C Ellen Lee1*, William D Leslie2 and YK James Lau3

Author Affiliations

1 Department of Physical Therapy, University of Manitoba, R106 - 771 McDermot Ave., Winnipeg MB R3E 0T6, Canada

2 Department of Medicine, University of Manitoba, St. Boniface Hospital, 409 Tache Ave., Winnipeg MB R2H 2A6, Canada

3 Eli Lilly Corporation, Lilly Corporate Center, Indianapolis, Indiana 46285, USA

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BMC Cancer 2012, 12:103  doi:10.1186/1471-2407-12-103

Published: 21 March 2012

Abstract

Background

Androgen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT.

Methods/Design

A 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data.

Discussion

Musculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT.

Trial registration

ClinicalTrials.gov: NCT00834392.

Keywords:
Prostate cancer; Androgen deprivation therapy; Walking; Home-based exercise; Bone health; Physical function; Quality of life