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

BMC Cancer. 2012 Mar 21;12:103. doi: 10.1186/1471-2407-12-103.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorptiometry, Photon
  • Analysis of Variance
  • Androgen Antagonists / adverse effects*
  • Androgen Antagonists / therapeutic use
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Body Composition / physiology
  • Body Mass Index
  • Bone Density / drug effects
  • Bone Density / physiology
  • Exercise Therapy*
  • Humans
  • Male
  • Musculoskeletal Diseases / prevention & control*
  • Pilot Projects
  • Prospective Studies
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / physiopathology
  • Quality of Life
  • Single-Blind Method
  • Walking

Substances

  • Androgen Antagonists
  • Antineoplastic Agents, Hormonal

Associated data

  • ClinicalTrials.gov/NCT00834392