Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000263493
Ethics application status
Approved
Date submitted
16/05/2007
Date registered
16/05/2007
Date last updated
26/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of exercise on reducing treatment-side effects in prostate cancer patients undergoing hormone therapy
Scientific title
Resistance and aerobic exercise for reducing treatment side-effects in men receiving androgen deprivation therapy (ADT) for prostate cancer
Secondary ID [1] 252303 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer, androgen deprivation therapy (ADT) 1802 0
Condition category
Condition code
Cancer 1890 1890 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1752 0
Treatment: Other
Comparator / control treatment
Control: no treatment
Control group
Active

Outcomes
Primary outcome [1] 2686 0
Muscle function: muscle strength and muscle endurance.
Timepoint [1] 2686 0
Baseline and post-test (12 weeks).
Primary outcome [2] 2687 0
Cardiorespiratory capacity: maximum oxygen uptake measured during a staged walking test on a motorized treadmill.
Timepoint [2] 2687 0
Baseline and post-test (12 weeks).
Primary outcome [3] 2688 0
Physical performance: repeated chair rise, usual and fast 6-m walk, 6-m backwards walk, stair climb, and 400-m walk.
Timepoint [3] 2688 0
Baseline and post-test (12 weeks).
Primary outcome [4] 2689 0
Body composition: whole body and regional muscle and fat tissue mass.
Timepoint [4] 2689 0
Baseline and post-test (12 weeks).
Primary outcome [5] 2690 0
Balance and risk of falling: Neurocom Smart Balancemaster will be used to assess static and dynamic balance.
Timepoint [5] 2690 0
Baseline and post-test (12 weeks).
Secondary outcome [1] 4544 0
Health-related quality of life: EORTC QLQ-C30 and EORTC QLQ-PR25.
Timepoint [1] 4544 0
Baseline and post-test (12 weeks).
Secondary outcome [2] 4545 0
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 [2] 4545 0
Baseline and post-test (12 weeks).

Eligibility
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.
Minimum age
50 Years
Maximum age
90 Years
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 2037 0
Charities/Societies/Foundations
Name [1] 2037 0
The Cancer Council Western Australia
Country [1] 2037 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
100 Joondalup Drive, Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 1845 0
Individual
Name [1] 1845 0
Professor Robert Newton
Address [1] 1845 0
Vario Health Institute, 100 Joondalup Drive, Joondalup WA 6027
Country [1] 1845 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3771 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 3771 0
Ethics committee country [1] 3771 0
Australia
Date submitted for ethics approval [1] 3771 0
Approval date [1] 3771 0
23/04/2007
Ethics approval number [1] 3771 0
07-53 GALVÃO

Summary
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.
Trial website
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 27855 0
Address 27855 0
Country 27855 0
Phone 27855 0
Fax 27855 0
Email 27855 0
Contact person for public queries
Name 10941 0
Dr Daniel Galvão
Address 10941 0
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
100 Joondalup Drive, Joondalup, WA 6027
Country 10941 0
Australia
Phone 10941 0
08-63045383
Fax 10941 0
Email 10941 0
[email protected]
Contact person for scientific queries
Name 1869 0
Dr Daniel Galvão
Address 1869 0
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
100 Joondalup Drive
Joondalup WA 6027
Country 1869 0
Australia
Phone 1869 0
08-63045383
Fax 1869 0
Email 1869 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIExercise maintains sexual activity in men undergoing androgen suppression for prostate cancer: a randomized controlled trial2013https://doi.org/10.1038/pcan.2012.52
Dimensions AICombined Resistance and Aerobic Exercise Program Reverses Muscle Loss in Men Undergoing Androgen Suppression Therapy for Prostate Cancer Without Bone Metastases: A Randomized Controlled Trial2009https://doi.org/10.1200/jco.2009.23.2488
N.B. These documents automatically identified may not have been verified by the study sponsor.