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Trial registered on ANZCTR


Registration number
ACTRN12616001311448
Ethics application status
Approved
Date submitted
14/09/2016
Date registered
19/09/2016
Date last updated
19/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of resistance training on androgen deprivation-induced adverse effects on protein metabolism, body composition and muscle function in prostate cancer patients
Scientific title
Impact of resistance training on androgen deprivation-induced adverse effects on protein metabolism, body composition and muscle function in prostate cancer patients
Secondary ID [1] 290157 0
Nil
Universal Trial Number (UTN)
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 300279 0
Condition category
Condition code
Cancer 300146 300146 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive resistance training for 12 months.
This is a self-managed structured 40 minute resistance exercise regimen 3 times a week
with 8-10 exercises targeting the major muscle groups using adjustable dumbbells and body weight loading (i.e. calisthenics). Loads will yield 8-12 repetitions maximum per set and calisthenics exercises and loads will be advanced with strength adaptation. One week of exercise supervision (3 sessions) will be provided at baseline to instruct participants in proper lifting techniques and loading progressions by exercise phisiologist. Online instructional videos and a printed training manual will also be provided for each exercise. Follow-up supervised sessions will be provided one session every 8 weeks of the intervention. Compliance to training will be recorded in a training log by the participants.
Intervention code [1] 295911 0
Lifestyle
Intervention code [2] 295923 0
Treatment: Other
Comparator / control treatment
Control group - no resistance training
Control group
Active

Outcomes
Primary outcome [1] 299633 0
Composite protein and urea turnover assessed by using stable isotopes, measured by GCMS.
Timepoint [1] 299633 0
6 weeks post commencement of intervention
Primary outcome [2] 299634 0
Muscle mass assessed by DXA
Timepoint [2] 299634 0
12 months post commencement of intervention
Primary outcome [3] 299643 0
Muscle function, assessed by cycle ergometer and dynamometer
Timepoint [3] 299643 0
12 months post commencement of intervention
Secondary outcome [1] 327716 0
Insulin sensitivity, assessed by oral glucose tolerance test
Timepoint [1] 327716 0
6 weeks, 6 months and 12 months post commencement of intervention
Secondary outcome [2] 327717 0
Bone turnover by serum assay
Timepoint [2] 327717 0
6 months and 12 months post commencement of intervention
Secondary outcome [3] 327718 0
Composite energy expenditure and substrate oxidation, assessed by indirect calorimeter
Timepoint [3] 327718 0
6 weeks, 6 months and 12 months post commencement of intervention

Eligibility
Key inclusion criteria
1. ECOG less than or equal to 1; histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (less than or equal to 5 sites of bone metastases only);
2. Plan to receive at least 12 months continuous androgen deprivation therapy by a GnRH agonist;
3. Normal insulin sensitivity, assessed by co-investigators;
4. Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study;
Minimum age
50 Years
Maximum age
80 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any acute condition or exacerbation of chronic conditions that in the investigators opinion would interfere with the trial visit schedule and procedures.
2. Concurrent chemotherapy or anti-androgen therapy;
3. Previous androgen deprivation therapy within last 12 months;
4. Hypothalamic or pituitary disorders, cancer other than prostate cancer, diabetes mellitus and chronic renal or hepatic illnesses;
5. Any medications known to interfere with the endocrine system (apart from ADT);
6. People in existing dependent or unequal relationships with any member of the research team;
7. People who may be involved in illegal activity;
8. People highly dependent on medical care;
9. Patients who had received an investigational new drug within the last 6 month;
10. Patients with a cognitive impairment, an intellectual disability or a mental condition which interfere with the patient's ability to understand the requirements of the study;
11. Inability to give written informed consent.

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)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
As above
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation from our pilot data in 12 prostate cancer patients show that with 28 men in each group, the study will have 80% power to detect significant (0.05) difference in ADT-induced reduction in LBM, deterioration in muscle strength between the resistance training group and the non-training group of 0.83 kg and 1.8 kg, respectively. From previous published studies, a sample size of 15 subjects in each arm is required to detect an increase in protein oxidation of 11% at a 80% power. Thus, 30 patients will be recruited in total.
Standard descriptive and statistical modelling approaches will be employed to analyse the data. Specifically, the treatment effects will be analysed by ANOVA with repeated measures. Regression analysis will be used to determine the correlations between physical activity scores and other endpoint measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6684 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 6685 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 14310 0
2148 - Blacktown
Recruitment postcode(s) [2] 14311 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294524 0
Hospital
Name [1] 294524 0
Blacktown Hospital
Address [1] 294524 0
Marcel Cres
Blacktown NSW 2148
Country [1] 294524 0
Australia
Primary sponsor type
Hospital
Name
Blacktown Hospital
Address
Marcel Cres
Blacktown NSW 2148
Country
Australia
Secondary sponsor category [1] 293387 0
None
Name [1] 293387 0
na
Address [1] 293387 0
na
Country [1] 293387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295957 0
WSLHD
Ethics committee address [1] 295957 0
Hawkesbury Rd & Darcy Road, Westmead NSW 2145
Ethics committee country [1] 295957 0
Australia
Date submitted for ethics approval [1] 295957 0
07/03/2014
Approval date [1] 295957 0
09/09/2014
Ethics approval number [1] 295957 0
HREC/14/WMEAD /110

Summary
Brief summary
The primary purpose of this trial is to investigate the efficacy of progressive resistance training for reducing the side effects of loss of muscle and increase in fat associated with androgen deprivation therapy (ADT) for men with prostate cancer.

Who is it for?
You may be eligible to enroll in this trial if you are aged 50-80 years and have been diagnosed with prostate cancer for which you are scheduled to receive ADT by a GnRH agonist.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to either the progressive resistance training group or the control group, who receive no training. Participants in the progressive resistance group will receive self-managed structured 40 minute resistance exercise regimen using dumbbells 3 times a week for 12 months.

It is hoped that this trial will provide information on the efficacy of progressive resistance training for reducing the loss of protein, muscle mass and function associated with ADT in prostate cancer patients.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 69062 0
Dr Vita Birzniece
Address 69062 0
School of Medicine, Western Sydney University
Blacktown Clinical School and Research Centre
Blacktown Hospital,
Marcel Cres, Blacktown NSW 2148
Country 69062 0
Australia
Phone 69062 0
+61298516059
Fax 69062 0
+61298516050
Email 69062 0
v.birzniece@westernsydney.edu.au
Contact person for public queries
Name 69063 0
Dr Vita Birzniece
Address 69063 0
School of Medicine, Western Sydney University
Blacktown Clinical School and Research Centre
Blacktown Hospital,
Marcel Cres, Blacktown NSW 2148
Country 69063 0
Australia
Phone 69063 0
+61298516059
Fax 69063 0
+61298516050
Email 69063 0
v.birzniece@westernsydney.edu.au
Contact person for scientific queries
Name 69064 0
Dr Vita Birzniece
Address 69064 0
School of Medicine, Western Sydney University
Blacktown Clinical School and Research Centre
Blacktown Hospital,
Marcel Cres, Blacktown NSW 2148
Country 69064 0
Australia
Phone 69064 0
+61298516059
Fax 69064 0
+61298516050
Email 69064 0
v.birzniece@westernsydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results