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Trial registered on ANZCTR


Registration number
ACTRN12609000200280
Ethics application status
Approved
Date submitted
30/03/2009
Date registered
21/04/2009
Date last updated
22/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
What types of exercise are most useful in reducing the side effects of hormonal therapy for prostate cancer
Scientific title
A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer
Secondary ID [1] 252936 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 4546 0
Condition category
Condition code
Cancer 4837 4837 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resistance/impact loading exercise group (1): progressive supervised resistance (e.g. upper and lower body resistance based exercises using weight machines) and impact loading exercises (e.g. skipping, bounding and drop jumping) twice weekly 60 minutes sessions during 12 months.
Resistance/cardiovascular exercise group (2): progressive supervised resistance (e.g. upper and lower body resistance based exercises using weight machines) and aerobic exercises (e.g. walking and cycling) twice weekly 60 minutes sessions during 6 months.
Intervention code [1] 4312 0
Treatment: Other
Comparator / control treatment
Control: usual care delay exercise group. All participants in this group will be provided with a printed booklet with information about exercise for the initial 6-month period. In the second 6-month period, supervised non impact aerobic exercise (cycling) sessions will be undertaken twice a week. Further, participants in this group will be also offered a 3-month resistance exercise program following the completion of the second 6-month period.
Control group
Active

Outcomes
Primary outcome [1] 5695 0
Cardiorespiratory capacity (maximum oxygen capacity) will be measured by expired air analysis during a staged walking test on a motorized treadmill. Exercise capacity (in METS) will be determined on the basis of the speed and grade of the treadmill as well as direct expired air gas analysis. Electrocardiogram will be recorded using a 12-lead monitoring system and blood pressure will be measured each testing minute by sphygmomanometer. This assessment will be conducted by medical doctor and an exercise physiologist.
Timepoint [1] 5695 0
Baseline, midpoint (6 months) and post-test (12 months).
Primary outcome [2] 5696 0
Hip, spine and whole body bone mineral density (BMD). BMD (g/cm2) of the hip (total hip) and lumbar spine (L2-4) regions as well as whole body bone mineral content (BMC, g) will be assessed by dual-energy X-ray absorptiometry (DXA, Hologic Discovery A, Waltham, MA). Assessments will be conducted by an exercise physiologist with bone densitometry certification.
Timepoint [2] 5696 0
Baseline, midpoint (6 months) and post-test (12 months).
Secondary outcome [1] 241601 0
Blood pressure and Artery Stiffness. A validated oscillometric device (HEM-705CP, Omron Corporation, Japan) will be used to record brachial blood pressure at the dominant arm in triplicate. Central (ascending aortic) blood pressure and indices of arterial stiffness will be determined by pulse wave analysis using SphygmoCor version 6.1 software (AtCor Medical, Sydney, Australia). Radial artery pressure waveforms will be captured at the right arm by applanation tonometry using a high fidelity micromanometer (SPC-301, Millar Instruments, Houston, Texas, USA). A generalised transfer function is applied to the radial artery waveform in order to obtain the pressure waveform at the ascending aorta. This method has been validated against invasive techniques for determination of central blood pressure and the augmentation index (AIx) is a marker of systemic arterial stiffness. Assessments will be conducted by an exercise physiologist.
Timepoint [1] 241601 0
Baseline, midpoint (6 months) and post-test (12 months).
Secondary outcome [2] 241602 0
Blood biomarkers: Blood laboratory analysis including levels of testosterone, prostate specific antigen (PSA), insulin, lipid profile, glucose, HbA1c, alkaline phosphatase, Pro collagen Type 1 N-Terminal Propeptide (PINP), and C- reactive protein (CRP) levels will be measured commercially by an accredited Australian National
Timepoint [2] 241602 0
Baseline, midpoint (6 months) and post-test (12 months).
Secondary outcome [3] 241603 0
Body composition (lean and fat mass). Regional and whole body lean mass (including appendicular skeletal muscle mass) and fat mass will be derived from a DXA whole body scan. Assessments will be conducted by an exercise physiologist with bone densitometry operator certification.
Timepoint [3] 241603 0
Baseline, midpoint (6 months) and post-test (12 months).
Secondary outcome [4] 241604 0
Physical and muscle function: muscle strength and endurance, repeated chair rise, usual and fast walk, backward walk, stair clim, 400-m walk.
Timepoint [4] 241604 0
Baseline, midpoint (6 months) and post-test (12 months).
Secondary outcome [5] 241605 0
Balance and risk of falling: Neurocom Smart Balancemaster will be used to assess static and dynamic balance.
Timepoint [5] 241605 0
Baseline, midpoint (6 months) and post-test (12 months).
Secondary outcome [6] 241606 0
Quality of life: European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer ? Prostate Specific Module (EORTC QLQ-PR25), Medical Outcomes Study Short-Form 36 (SF-36), and The Brief Symptom Inventory-18 (BSI-18).
Timepoint [6] 241606 0
Baseline, midpoint (6 months) and post-test (12 months).

Eligibility
Key inclusion criteria
Prostate cancer patients on androgen suppression (for>2 month) and who are anticipated to remain hypogonadal for the duration of the study (12 months).
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(1) metastatic bone disease, established osteoporosis or taking medications known to affect bone metabolism, such as bisphosphonates; (2) presence of musculoskeletal, neurological or cardiovascular disorder that could inhibit them from exercising (will required a GP consent); (3) participated in regular (e.g. 2 to 3 times per week) resistance training in the previous 3 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
195
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 1571 0
6027
Recruitment postcode(s) [2] 1572 0
6050
Recruitment postcode(s) [3] 1573 0
6009
Recruitment postcode(s) [4] 1574 0
6210
Recruitment postcode(s) [5] 1575 0
6164
Recruitment postcode(s) [6] 1576 0
6260
Recruitment postcode(s) [7] 1577 0
4000

Funding & Sponsors
Funding source category [1] 4734 0
Government body
Name [1] 4734 0
National Health and Medical Research Council (NHMRC)
Country [1] 4734 0
Australia
Funding source category [2] 4735 0
Charities/Societies/Foundations
Name [2] 4735 0
Prostate Cancer Foundation of Australia (PCFA)
Country [2] 4735 0
Australia
Funding source category [3] 4736 0
Charities/Societies/Foundations
Name [3] 4736 0
The Cancer Council of Western Australia
Country [3] 4736 0
Australia
Funding source category [4] 4737 0
Charities/Societies/Foundations
Name [4] 4737 0
The Cancer Council of Queensland
Country [4] 4737 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup, 6027 WA
Country
Australia
Secondary sponsor category [1] 4277 0
Individual
Name [1] 4277 0
Professor Robert Newton
Address [1] 4277 0
270 Joondalup Drive, Joondalup, 6027 WA
Country [1] 4277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6778 0
Edith Cowan University Human Research Ethics
Ethics committee address [1] 6778 0
270 Joondalup Drive, Joondalup, 6027 WA
Ethics committee country [1] 6778 0
Australia
Date submitted for ethics approval [1] 6778 0
Approval date [1] 6778 0
21/05/2008
Ethics approval number [1] 6778 0
08-69NEWTON

Summary
Brief summary
This study looks at which types of exercise are most useful in reducing the side effects of hormonal therapy for prostate cancer.

Who is it for?
You can join this study if you are a man being treated for prostate cancer with androgen deprivation therapy (ADT) to reduce your level of male hormones.

Trial details
Participants will be divided into three groups. One group will undertake resistance/impact loading exercise. Sessions are 60 minutes each, twice weekly over 12 months. The second group will undertake resistance/cardiovascular exercise. Sessions are 60 minutes each, twice weekly over 6 months. The third group will be provided with a printed booklet with information about exercise for the initial 6-month period, and in the second 6-month period undertake twice weekly cycling exercise sessions. Participants in this group will be also offered a 3-month resistance exercise program following the completion of the second 6-month period. The study will measure cardio-respiratory capacity (maximum oxygen capacity), bone mineral density, blood pressure and artery stiffness, muscle function and other indicators of well-being before, during and immediately after the program. The use of androgen deprivation therapy (ADT) is accompanied by a number of side effects. This study will investigate the effects of exercise on reversing musculoskeletal and cardiovascular related side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29453 0
Address 29453 0
Country 29453 0
Phone 29453 0
Fax 29453 0
Email 29453 0
Contact person for public queries
Name 12700 0
Dr Daniel Galvao
Address 12700 0
270 Joondalup Drive, Joondalup, WA 6027
Country 12700 0
Australia
Phone 12700 0
+61 08 6304 3420
Fax 12700 0
Email 12700 0
[email protected]
Contact person for scientific queries
Name 3628 0
Dr Daniel Galvao
Address 3628 0
270 Joondalup Drive, Joondalup, WA 6027
Country 3628 0
Australia
Phone 3628 0
+61 08 6304 3420
Fax 3628 0
Email 3628 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
EmbaseMaximal exercise testing of men with prostate cancer being treated with androgen deprivation therapy.2014https://dx.doi.org/10.1249/MSS.0000000000000353
N.B. These documents automatically identified may not have been verified by the study sponsor.