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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082014
ACTR Number:
ACTRN12607000263493
Trial Status:
Registered
Date Submitted:
16/05/2007
Date Registered:
16/05/2007
Page 1
Public title:
Effects of exercise on reducing treatment-side effects in prostate cancer patients undergoing hormone therapy
Update:
Reason:
ANZCTR registration title:
Resistance and aerobic exercise for reducing treatment side-effects in men receiving androgen deprivation therapy (ADT) for prostate cancer
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Secondary ID:
None.
UTN:
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Trial acronym:
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Page 2
Health condition(s) or problem(s) studied:
Prostate cancer, androgen deprivation therapy (ADT)
Condition category:
Condition code:
Cancer
Prostate
Page 3
Description of intervention(s) / exposure:
Exercise: progressive supervised aerobic (e.g. walking and cycling) and resistance exercises (e.g. upper and lower body resistance based exercise using weight machines) twice weekly (60 minutes session) during 12 weeks.
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Reason:
Intervention code:
Treatment: Other
Comparator / control treatment:
Control: no treatment
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Control group:
Active
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Reason:
Page 4
Primary outcome 1:
Muscle function: muscle strength and muscle endurance.
Timepoint:
Baseline and post-test (12 weeks).
Primary outcome 2:
Cardiorespiratory capacity: maximum oxygen uptake measured during a staged walking test on a motorized treadmill.
Timepoint:
Baseline and post-test (12 weeks).
Primary outcome 3:
Physical performance: repeated chair rise, usual and fast 6-m walk, 6-m backwards walk, stair climb, and 400-m walk.
Timepoint:
Baseline and post-test (12 weeks).
Primary outcome 4:
Body composition: whole body and regional muscle and fat tissue mass.
Timepoint:
Baseline and post-test (12 weeks).
Primary outcome 5:
Balance and risk of falling: Neurocom Smart Balancemaster will be used to assess static and dynamic balance.
Timepoint:
Baseline and post-test (12 weeks).
Secondary outcome 1:
Health-related quality of life: EORTC QLQ-C30 and EORTC QLQ-PR25.
Timepoint:
Baseline and post-test (12 weeks).
Secondary outcome 2:
Blood markers: prostate specific antigen (PSA), testosterone, insulin, growth hormone, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol and plasma glucose.
Timepoint:
Baseline and post-test (12 weeks).
Page 5
Key inclusion criteria:
Prostate cancer patients undergoing androgen deprivation therapy for at least 2 months and who are anticipated to remain hypogonadal for the duration of the study (12 weeks), consent from physician, and able to walk 400m and undertake upper and lower body exercises.
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Minimum Age:
50
Years
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Maximum Age:
90
Years
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Gender:
Males
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Healthy volunteers?
No
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Key exclusion criteria:
Bone metastases, musculoskeletal, neurological or cardiovascular disorder that could inhibit the participant from exercising, participated in regular (e.g. 2 to 3 times per week) resistance training in the previous 12 months.
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Reason:
Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
central randomisation by computer
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Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
computerised sequence generation
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Masking / blinding:
Open (masking not used)
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Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Efficacy
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Page 7
Phase
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Anticipated or actual date of first participant enrolement:
1/06/2007
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Target sample size:
60
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Recruitment status:
Completed
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Reason:
Page 8
Funding source:
Charities/Societies/Foundations
Name:
The Cancer Council Western Australia
Address:
46 Ventnor Avenue West Perth 6005 Western Australia
Country:
Australia
Primary sponsor:
University
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Reason:
Name:
Edith Cowan University
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Reason:
Address:
100 Joondalup Drive, Joondalup, WA 6027
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Country:
Australia
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Secondary sponsor:
Individual
Name:
Professor Robert Newton
Address:
Vario Health Institute, 100 Joondalup Drive, Joondalup WA 6027
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
Edith Cowan University Human Research Ethics Committee
Address:
Country:
Australia
Date of approval:
23/04/2007
HREC Number:
07-53 GALVÃO
Countries of recruitment:
Australia
Brief summary:
The use of androgen deprivation therapy (ADT) to reduce testosterone levels in men with prostate carcinoma is accompanied by a number of adverse side effects. This study will investigate the effects of aerobic and resistance exercise on reversing musculoskeletal and cardiorespiratory related side effects in prostate cancer patients undertaking ADT.
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Reason:
Trial website:
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Presentations / publication list:
Galvão DA, Taaffe DR, Spry N, Joseph D, Newton RU. A 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: 340–347.
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Page 10
Contact person for public queries
Name:
Dr Daniel Galvão
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Address:
School of Exercise, Biomedical and Health Sciences Edith Cowan University 100 Joondalup Drive, Joondalup, WA 6027
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Country:
Australia
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Tel:
08-63045383
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Fax:
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Email:
d.galvao@ecu.edu.au
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Reason:
Contact person for scientific queries
Name:
Dr Daniel Galvão
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Reason:
Address:
School of Exercise, Biomedical and Health Sciences Edith Cowan University 100 Joondalup Drive Joondalup WA 6027
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Country:
Australia
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Tel:
08-63045383
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Email:
d.galvao@ecu.edu.au
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