Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Cancer
Published in: BMC Cancer 1/2011

Open Access 01-12-2011 | Study protocol

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial

Authors: Daniel A Galvão, Dennis R Taaffe, Prue Cormie, Nigel Spry, Suzanne K Chambers, Carolyn Peddle-McIntyre, Michael Baker, James Denham, David Joseph, Geoff Groom, Robert U Newton

Published in: BMC Cancer | Issue 1/2011

Login to get access

Abstract

Background

The presence of bone metastases has excluded participation of prostate cancer patients in exercise intervention studies to date and is also a relative contraindication to supervised exercise in the community setting because of concerns of fragility fracture. However, this group of patients often have developed significant muscle atrophy and functional impairments from prior and continuing androgen deprivation that is exacerbated by subsequent and more intensive interventions such as chemotherapy. The aim of this study is to determine the efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases.

Methods/Design

Multi-site randomized controlled trial in Western Australia and New South Wales to examine the efficacy and safety of a modular multi-modal physical exercise program in 90 prostate cancer survivors with bone metastases. Participants will be randomized to (1) modular multi-modal exercise intervention group or (2) usual medical care group. The modular multi-modal exercise group will receive a 3-month supervised exercise program based on bone lesion location/extent. Measurements for primary and secondary endpoints will take place at baseline, 3 months (end of the intervention) and 6 months follow-up.

Discussion

Delaying or preventing skeletal complication and improving physical function for men with bone metastases would provide clinically meaningful benefits to patients. However, exercise programs must be designed and executed with careful consideration of the skeletal complications associated with bone metastatic disease and cumulative toxicities from androgen deprivation such as osteoporosis and increased risk of fractures. The results from this study will form the basis for the development of a specific exercise prescription in this patient group in order to alleviate disease burden, counteract the adverse treatment related side-effects and enhance quality of life.

Trial Registration

ACTRN: ACTRN12611001158​954
Literature
1.
Small EJ, Smith MR, Seaman JJ, Petrone S, Kowalski MO: Combined analysis of two multicenter, randomized, placebo-controlled studies of pamidronate disodium for the palliation of bone pain in men with metastatic prostate cancer. J Clin Oncol. 2003, 21 (23): 4277-4284. 10.1200/JCO.2003.05.147.CrossRefPubMed
2.
Fizazi K, Beuzeboc P, Lumbroso J, Haddad V, Massard C, Gross-Goupil M, Di Palma M, Escudier B, Theodore C, Loriot Y, et al: Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol. 2009, 27 (15): 2429-2435. 10.1200/JCO.2008.18.9811.CrossRefPubMed
3.
Carlin BI, Andriole GL: The natural history, skeletal complications, and management of bone metastases in patients with prostate carcinoma. Cancer. 2000, 88 (12 Suppl): 2989-2994.CrossRefPubMed
4.
Saad F, Olsson C, Schulman CC: Skeletal morbidity in men with prostate cancer: quality-of-life considerations throughout the continuum of care. Eur Urol. 2004, 46 (6): 731-739. 10.1016/j.eururo.2004.08.016. discussion 739-740CrossRefPubMed
5.
Jemal A, Siegel R, Xu J, Ward E: Cancer statistics. CA Cancer J Clin. 2010, 60 (5): 277-300. 10.3322/caac.20073.CrossRefPubMed
6.
Lee RJ, Saylor PJ, Smith MR: Treatment and prevention of bone complications from prostate cancer. Bone. 2011, 48 (1): 88-95. 10.1016/j.bone.2010.05.038.CrossRefPubMed
7.
Weinfurt KP, Li Y, Castel LD, Saad F, Timbie JW, Glendenning GA, Schulman KA: The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer. Ann Oncol. 2005, 16 (4): 579-584. 10.1093/annonc/mdi122.CrossRefPubMed
8.
Shahinian VB, Kuo YF, Freeman JL, Goodwin JS: Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005, 352 (2): 154-164. 10.1056/NEJMoa041943.CrossRefPubMed
9.
Sharifi N, Gulley JL, Dahut WL: Androgen deprivation therapy for prostate cancer. JAMA. 2005, 294 (2): 238-244. 10.1001/jama.294.2.238.CrossRefPubMed
10.
Diamond TH, Higano CS, Smith MR, Guise TA, Singer FR: Osteoporosis in men with prostate carcinoma receiving androgen-deprivation therapy: recommendations for diagnosis and therapies. Cancer. 2004, 100 (5): 892-899. 10.1002/cncr.20056.CrossRefPubMed
11.
Galvao DA, Spry NA, Taaffe DR, Newton RU, Stanley J, Shannon T, Rowling C, Prince R: Changes in muscle, fat and bone mass after 36 weeks of maximal androgen blockade for prostate cancer. BJU Int. 2008, 102 (1): 44-47. 10.1111/j.1464-410X.2008.07539.x.CrossRefPubMed
12.
Galvao DA, Taaffe DR, Spry N, Joseph D, Turner D, Newton RU: Reduced muscle strength and functional performance in men with prostate cancer undergoing androgen suppression: a comprehensive cross-sectional investigation. Prostate Cancer Prostatic Dis. 2009, 12 (2): 198-203. 10.1038/pcan.2008.51.CrossRefPubMed
13.
Ebeling PR: Clinical practice. Osteoporosis in men. N Engl J Med. 2008, 358 (14): 1474-1482. 10.1056/NEJMcp0707217.CrossRefPubMed
14.
Oefelein MG, Ricchiuti V, Conrad W, Resnick MI: Skeletal fractures negatively correlate with overall survival in men with prostate cancer. J Urol. 2002, 168 (3): 1005-1007. 10.1016/S0022-5347(05)64561-2.CrossRefPubMed
15.
Petrylak DP, Tangen CM, Hussain MH, Lara PN, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004, 351 (15): 1513-1520. 10.1056/NEJMoa041318.CrossRefPubMed
16.
Oudard S, Banu E, Beuzeboc P, Voog E, Dourthe LM, Hardy-Bessard AC, Linassier C, Scotte F, Banu A, Coscas Y, et al: Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer. J Clin Oncol. 2005, 23 (15): 3343-3351. 10.1200/JCO.2005.12.187.CrossRefPubMed
17.
Coleman RE: Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001, 27 (3): 165-176. 10.1053/ctrv.2000.0210.CrossRefPubMed
18.
Eton DT, Lepore SJ: Prostate cancer and health-related quality of life: a review of the literature. Psychooncology. 2002, 11 (4): 307-326. 10.1002/pon.572.CrossRefPubMedPubMedCentral
19.
Albertsen PC, Aaronson NK, Muller MJ, Keller SD, Ware JE: Health-related quality of life among patients with metastatic prostate cancer. Urology. 1997, 49 (2): 207-216. 10.1016/S0090-4295(96)00485-2. discussion 216-207CrossRefPubMed
20.
Windsor PM, Nicol KF, Potter J: A randomized, controlled trial of aerobic exercise for treatment-related fatigue in men receiving radical external beam radiotherapy for localized prostate carcinoma. Cancer. 2004, 101 (3): 550-557. 10.1002/cncr.20378.CrossRefPubMed
21.
Galvao DA, Nosaka K, Taaffe DR, Peake J, Spry N, Suzuki K, Yamaya K, McGuigan MR, Kristjanson LJ, Newton RU: Endocrine and immune responses to resistance training in prostate cancer patients. Prostate Cancer Prostatic Dis. 2008, 11 (2): 160-165. 10.1038/sj.pcan.4500991.CrossRefPubMed
22.
Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU: Combined resistance and aerobic exercise program reverses muscle loss in men undergoing androgen suppression therapy for prostate cancer without bone metastases: a randomized controlled trial. J Clin Oncol. 2010, 28 (2): 340-347. 10.1200/JCO.2009.23.2488.CrossRefPubMed
23.
Galvao DA, Nosaka K, Taaffe DR, Spry N, Kristjanson LJ, McGuigan MR, Suzuki K, Yamaya K, Newton RU: Resistance training and reduction of treatment side effects in prostate cancer patients. Med Sci Sports Exerc. 2006, 38 (12): 2045-2052. 10.1249/01.mss.0000233803.48691.8b.CrossRefPubMed
24.
Segal RJ, Reid RD, Courneya KS, Sigal RJ, Kenny GP, Prud'Homme DG, Malone SC, Wells GA, Scott CG, Slovinec D'Angelo ME: Randomized controlled trial of resistance or aerobic exercise in men receiving radiation therapy for prostate cancer. J Clin Oncol. 2009, 27 (3): 344-351.CrossRefPubMed
25.
Segal RJ, Reid RD, Courneya KS, Malone SC, Parliament MB, Scott CG, Venner PM, Quinney HA, Jones LW, D'Angelo ME, et al: Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol. 2003, 21 (9): 1653-1659. 10.1200/JCO.2003.09.534.CrossRefPubMed
26.
Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, et al: American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010, 42 (7): 1409-1426. 10.1249/MSS.0b013e3181e0c112.CrossRefPubMed
27.
Galvao DA, Taaffe DR: Resistance exercise dosage in older adults: single- versus multiset effects on physical performance and body composition. J Am Geriatr Soc. 2005, 53 (12): 2090-2097. 10.1111/j.1532-5415.2005.00494.x.CrossRefPubMed
28.
Taaffe DR, Duret C, Wheeler S, Marcus R: Once-weekly resistance exercise improves muscle strength and neuromuscular performance in older adults. J Am Geriatr Soc. 1999, 47 (10): 1208-1214.CrossRefPubMed
29.
Myers AM, Fletcher PC, Myers AH, Sherk W: Discriminative and evaluative properties of the activities-specific balance confidence (ABC) scale. J Gerontol A Biol Sci Med Sci. 1998, 53 (4): M287-294.CrossRefPubMed
30.
Taaffe DR, Henwood TR, Nalls MA, Walker DG, Lang TF, Harris TB: Alterations in muscle attenuation following detraining and retraining in resistance-trained older adults. Gerontology. 2009, 55 (2): 217-223. 10.1159/000182084.CrossRefPubMed
31.
Ware JE, Gandek B: Overview of the SF-36 health survey and the international quality of life assessment (IQOLA) project. J Clin Epidemiol. 1998, 51 (11): 903-912. 10.1016/S0895-4356(98)00081-X.CrossRefPubMed
32.
Broom R, Du H, Clemons M, Eton D, Dranitsaris G, Simmons C, Ooi W, Cella D: Switching breast cancer patients with progressive bone metastases to third-generation bisphosphonates: measuring impact using the functional assessment of cancer therapy-bone pain. J Pain Symptom Manage. 2009, 38 (2): 244-257. 10.1016/j.jpainsymman.2008.08.005.CrossRefPubMed
33.
Sayers SP, Jette AM, Haley SM, Heeren TC, Guralnik JM, Fielding RA: Validation of the late-life function and disability instrument. J Am Geriatr Soc. 2004, 52 (9): 1554-1559. 10.1111/j.1532-5415.2004.52422.x.CrossRefPubMed
34.
Chambers SK, Lynch BM, Aitken J, Baade P: Relationship over time between psychological distress and physical activity in colorectal cancer survivors. J Clin Oncol. 2009, 27 (10): 1600-1606. 10.1200/JCO.2008.18.5157.CrossRefPubMed
35.
Roth AJ, Rosenfeld B, Kornblith AB, Gibson C, Scher HI, Curley-Smart T, Holland JC, Breitbart W: The memorial anxiety scale for prostate cancer: validation of a new scale to measure anxiety in men with with prostate cancer. Cancer. 2003, 97 (11): 2910-2918. 10.1002/cncr.11386.CrossRefPubMed
36.
Sundin EC, Horowitz MJ: Impact of event scale: psychometric properties. Br J Psychiatry. 2002, 180: 205-209. 10.1192/bjp.180.3.205.CrossRefPubMed
37.
Reddy S, Bruera E, Pace E, Zhang K, Reyes-Gibby CC: Clinically important improvement in the intensity of fatigue in patients with advanced cancer. J Palliat Med. 2007, 10 (5): 1068-1075. 10.1089/jpm.2007.0007.CrossRefPubMed
38.
Cramp F, Daniel J: Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2008, 16 (2): CD006145-
39.
Beck SL, Schwartz AL, Towsley G, Dudley W, Barsevick A: Psychometric evaluation of the Pittsburgh sleep quality index in cancer patients. J Pain Symptom Manage. 2004, 27 (2): 140-148. 10.1016/j.jpainsymman.2003.12.002.CrossRefPubMed
40.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989, 28 (2): 193-213. 10.1016/0165-1781(89)90047-4.CrossRefPubMed
41.
Ajzen I: The theory of planned behavior. Orgn Behav Hum Dec Processes. 1991, 50: 179-211. 10.1016/0749-5978(91)90020-T.CrossRef
42.
Plasqui G, Westerterp KR: Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity (Silver Spring). 2007, 15 (10): 2371-2379. 10.1038/oby.2007.281.CrossRef
43.
Galvao DA, Spry N, Taaffe DR, Denham J, Joseph D, Lamb DS, Levin G, Duchesne G, Newton RU: A randomized controlled trial of an exercise intervention targeting cardiovascular and metabolic risk factors for prostate cancer patients from the RADAR trial. BMC Cancer. 2009, 9 (1): 419-10.1186/1471-2407-9-419.CrossRefPubMedPubMedCentral
44.
Newton RU, Taaffe DR, Spry N, Gardiner RA, Levin G, Wall B, Joseph D, Chambers SK, Galvao DA: A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer. BMC Cancer. 2009, 9: 210-10.1186/1471-2407-9-210.CrossRefPubMedPubMedCentral
45.
Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU: Acute versus chronic exposure to androgen suppression for prostate cancer: impact on the exercise response. J Urol. 2011, 186 (4): 1291-1297. 10.1016/j.juro.2011.05.055.CrossRefPubMed
46.
Newton RU, Hakkinen K, Hakkinen A, McCormick M, Volek J, Kraemer WJ: Mixed-methods resistance training increases power and strength of young and older men. Med Sci Sports Exerc. 2002, 34 (8): 1367-1375. 10.1097/00005768-200208000-00020.CrossRefPubMed
47.
Galvao DA, Newton RU: Review of exercise intervention studies in cancer patients. J Clin Oncol. 2005, 23 (4): 899-909. 10.1200/JCO.2005.06.085.CrossRefPubMed
Metadata
Title
Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial
Authors
Daniel A Galvão
Dennis R Taaffe
Prue Cormie
Nigel Spry
Suzanne K Chambers
Carolyn Peddle-McIntyre
Michael Baker
James Denham
David Joseph
Geoff Groom
Robert U Newton
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2011
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-11-517

Other articles of this Issue 1/2011

BMC Cancer 1/2011 Go to the issue

Research article

Coffee consumption and risk of cancers: a meta-analysis of cohort studies

Research article

Adjuvant Radio-chemotherapy for extrahepatic biliary tract cancers

Research article

Interaction and uptake of exosomes by ovarian cancer cells

Study protocol

A randomised trial of a psychosocial intervention for cancer patients integrated into routine care: the PROMPT study (promoting optimal outcomes in mood through tailored psychosocial therapies)

Research article

Integrated genomics of ovarian xenograft tumor progression and chemotherapy response

Research article

Correlation of microarray-based breast cancer molecular subtypes and clinical outcomes: implications for treatment optimization
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits