Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000097842
Ethics application status
Approved
Date submitted
18/01/2012
Date registered
20/01/2012
Date last updated
21/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Can exercise reduce treatment toxicity during the initial phase of testosterone suppression in prostate cancer patients?
Scientific title
Can exercise ameliorate treatment toxicity during the initial phase of testosterone suppression in prostate cancer patients; is this more effective than delayed rehabilitation and what is the time course and persistence of benefits?
Secondary ID [1] 279717 0
Nil
Universal Trial Number (UTN)
U1111-1127-1223
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 285553 0
Condition category
Condition code
Cancer 285745 285745 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate Exercise Group:
The exercise program involves resistance (e.g. lifting weights), aerobic (e.g. walking, cycling, rowing ergometer) and impact-loading (e.g. hopping, jumping) exercises undertaken 3 times per week for 6 months in an exercise clinic. Sessions will take approximately 60 minutes including the warm-up and cool-down periods. The sessions will be conducted in small groups of up to 6-10 participants under the supervision of exercise physiologists. The exercise program will be tailored to each participant. Target intensity will be 60-85% estimated maximum heart (220 – age) for aerobic exercise and 6-12 repetition maximum (i.e. a 6 repetition maximum is how much weight can be lifted 6 times) for resistance exercise.
Intervention code [1] 284014 0
Lifestyle
Comparator / control treatment
Delayed Exercise Group:
Participants will remain on their usual care for the initial 6 months, then will receive the same, 6 month exercise intervention as the Immediate Exercise Group.
Control group
Active

Outcomes
Primary outcome [1] 286270 0
Areal Bone Mineral Density (BMD): BMD of the hip, lumbar spine as well as whole body bone mineral content (BMC, g) will be assessed by dual-energy X-ray absorptiometry.
Timepoint [1] 286270 0
Baseline, 3 months, 6 months and 12 months
Secondary outcome [1] 295473 0
Volumetric BMD and Bone Architecture: volumetric BMD and micro-architecture at the tibia will be assessed by peripheral quantitative computed tomography.
Timepoint [1] 295473 0
Baseline, 3 months, 6 months and 12 months
Secondary outcome [2] 295474 0
Body Composition: regional and whole body lean mass and fat mass will be assessed by dual-energy X-ray absorptiometry.
Timepoint [2] 295474 0
Baseline, 3 months, 6 months and 12 months
Secondary outcome [3] 295475 0
Blood Markers: Testosterone, prostate specific antigen (PSA), insulin, glucose, hemoglobin A1c (HbA1c), C- reactive protein (CRP), bone formation [alkaline phosphatase, Pro collagen Type 1 N-Terminal Pro peptide (PINP)] and resorption [C-terminal telopeptide of type I collagen (CTX)] markers and lipid profile levels will be measured commercially by an accredited Australian National Association of Testing Authorities (NATA) laboratory.
Timepoint [3] 295475 0
Baseline, 3 months, 6 months and 12 months
Secondary outcome [4] 295476 0
Blood Pressure and Arterial Stiffness: blood pressure and arterial stiffness will be measured using standard protocols using a validated oscillometric device and the SphygmoCor system.
Timepoint [4] 295476 0
Baseline, 6 months and 12 months
Secondary outcome [5] 295477 0
Muscle Strength: Dynamic muscular strength of majour upper and lower body muscles will be assessed by standard 1RM protocol.
Timepoint [5] 295477 0
Baseline, 6 months and 12 months
Secondary outcome [6] 295478 0
Balance: static and dynamic balance will be assessed using the Neurocom Smart Balancemaster. Falls self-efficacy will be determined using the Activities-Specific Balance Confidence scale.
Timepoint [6] 295478 0
Baseline, 6 months and 12 months
Secondary outcome [7] 295479 0
Physicall Function: funcation performance will be assessed using standard measures including 1) 400m walk, 2) repeated chair rise, 3) stair climb, 4) 6-meter backward tandem walk, and 5) 6-meter walk, usual and fast pace.
Timepoint [7] 295479 0
Baseline, 6 months and 12 months
Secondary outcome [8] 295480 0
Physical Activity: physical activity and sedentary time will be assessed using triaxial accelerometry, the godin leisure-time questionnaire and sedentary time questionnaire.
Timepoint [8] 295480 0
Baseline, 6 months and 12 months
Secondary outcome [9] 295481 0
Physical Activity Motivation: physicaal activity motivation will be assessed using Theory of Planned Behaviour (TBP) constructs (affective and instrumental attitude, injunctive and descriptive norm, self-efficacy, perceived behavioural control, intention, and planning) in a standard TPB Questionnaire.
Timepoint [9] 295481 0
Baseline, 6 months and 12 months
Secondary outcome [10] 295482 0
Quality of Life: quality of life will be assessed using the SF-36, EORTC QLQ-C30, EORTC QLQ-PR25 and EPIC-26 questionnaires.
Timepoint [10] 295482 0
Baseline, 6 months and 12 months
Secondary outcome [11] 295483 0
Psychological Distress: psychological distress will be assessed using the Brief Symptom Inventory-18, Impact of Events Scale and Memorial Anxiety Scale for Prostate Cancer questionnaires.
Timepoint [11] 295483 0
Baseline, 6 months and 12 months
Secondary outcome [12] 295484 0
Fatigue: Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire.
Timepoint [12] 295484 0
Baseline, 6 months and 12 months
Secondary outcome [13] 295485 0
Sleep Quality: sleep quality will be assessed using the the Pittsburgh Sleep Quality Index.
Timepoint [13] 295485 0
Baseline, 6 months and 12 months

Eligibility
Key inclusion criteria
Men initiating androgen supression therapy (AST) for the treatment of prostate cancer
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Prior exposure to AST (e.g. those re-initiating AST from intermittent programs)
2) Established metastatic bone disease
3) Established osteoporosis
4) Taking medications known to affect bone metabolism (e.g. bisphosphonates),
5) Any acute illness, musculoskeletal, cardiovascular or neurological disorder that could inhibit a participant's
ability to participate in the exercise program or put them at risk of injury or illness.

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 randomization by computer. Written informed consent will be required prior to any testing or randomisation. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation). Randomisation is at the level of the individual patient, and will be stratified by age and smoking status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The two groups of participants receive different interventions during the same time span of the study, however the delayed exercise group receive the intervention after 6 months of usual care.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 284498 0
Charities/Societies/Foundations
Name [1] 284498 0
Cancer Australia
Country [1] 284498 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 283428 0
Individual
Name [1] 283428 0
Professor Robert Newton
Address [1] 283428 0
Edith Cowan University
270 Joondalup Drive, Joondalup WA 6027
Country [1] 283428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286480 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 286480 0
Edith Cowan University
270 Joondalup Drive, Joondalup WA 6027
Ethics committee country [1] 286480 0
Date submitted for ethics approval [1] 286480 0
11/01/2012
Approval date [1] 286480 0
Ethics approval number [1] 286480 0

Summary
Brief summary
This study aims to determine if immediate exercise therapy can improve health by reducing initial adverse effects during the initial phase of AST and if this provides superior benefits to delayed exercise therapy.

Who is it for?
You may be eligible to join this study if you are a man with prostate cancer who is about to initiate AST.

Trial details.
Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will immediately undergo supervised exercise training 3 times per week for 6 months. This involves aerobic (walking/jogging, cycling, rowing), resistance (lifting weights), and impact (hopping, jumping) exercises and then monitored (without training) for a further 6months. The other group will be assigned to usual care for the first 6 months. After this time participants in this group will commence the exercise program for the next 6 months.

Participants will have measurements of bone mineral density, body composition, blood markers, blood pressure, arterial stiffness taken at 4 occasions (baseline, 3-, 6-, and 12-months). Participants will also complete tests of their muscle strength, balance and physical function as well as complete a series of questionnaires at these time points.
Trial website
http://www.ecuhealthwellnessinstitute.org/research-activity/projects
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33624 0
Address 33624 0
Country 33624 0
Phone 33624 0
Fax 33624 0
Email 33624 0
Contact person for public queries
Name 16871 0
Professor Robert Newton
Address 16871 0
Edith Cowan University
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 16871 0
Australia
Phone 16871 0
+61 08 6304 5037
Fax 16871 0
Email 16871 0
[email protected]
Contact person for scientific queries
Name 7799 0
Professor Robert Newton
Address 7799 0
Edith Cowan University
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 7799 0
Australia
Phone 7799 0
+61 08 6304 5037
Fax 7799 0
Email 7799 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 AICan exercise ameliorate treatment toxicity during the initial phase of testosterone deprivation in prostate cancer patients? Is this more effective than delayed rehabilitation?2012https://doi.org/10.1186/1471-2407-12-432
Dimensions AIRadiotherapy before or during androgen-deprivation therapy does not blunt the exercise-induced body composition protective effects in prostate cancer patients: A secondary analysis of two randomized controlled trials2021https://doi.org/10.1016/j.exger.2021.111427
N.B. These documents automatically identified may not have been verified by the study sponsor.