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Trial registered on ANZCTR


Registration number
ACTRN12618000853246
Ethics application status
Approved
Date submitted
30/04/2018
Date registered
21/05/2018
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of a tailored exercise program on prostate cancer patients treated with androgen deprivation therapy: A pilot interventional study in the Australian regional setting
Scientific title
Impact of a tailored exercise program on prostate cancer patients treated with androgen deprivation therapy: A pilot interventional study in the Australian regional setting
Secondary ID [1] 294572 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 307632 0
Condition category
Condition code
Cancer 306700 306700 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Tailored exercise program run by exercise physiologists

Description:
- Supervised by exercise physiologists
- Mode of delivery is face-to-face
- 3x 30 minute one-on-one sessions (over 1-2 week period)
- Followed by weekly group training sessions for 14 weeks, 1 hour each
- Also home-based exercises in-between sessions (30 minutes daily; patient to keep diary to monitor adherence)
- Combination of resistance and aerobic exercises will be utilised in the individual, group and home-based program, including use of body weight, resistance bands and free weights to target major muscle groups
- Target intensity is low-moderate intensity
- Intervention is tailored to each individual based on exercise physiologist assessment, including weights used, number of repetitions and sets, and target intensity, to improve safety and adherence
- Pre- and post-intervention assessment consultations with exercise physiologist, 45 minutes each
- Location: local health and fitness centre
Intervention code [1] 301045 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305702 0
General health-related quality of life, as assessed using FACIT-F validated questionnaire
Timepoint [1] 305702 0
Baseline and 1 week post intervention completion
Primary outcome [2] 305703 0
Disease-specific health-related quality of life, as assessed using EPIC-CP validated questionnaire
Timepoint [2] 305703 0
Baseline and 1 week post-intervention completion
Primary outcome [3] 305704 0
Fatigue, as assessed with FACIT-F validated questionnaire
Timepoint [3] 305704 0
Baseline and 1 week post-intervention completion
Secondary outcome [1] 346198 0
Sexual function, as assessed using sexual function subscale of EPIC-CP validated questionnaire
Timepoint [1] 346198 0
Baseline and 1 week post-intervention completion
Secondary outcome [2] 346199 0
Body composition, assessed using DEXA body composition scan, and measurements of weight, BMI and waist circumference (composite secondary outcome)
Timepoint [2] 346199 0
Baseline and 1 week post-intervention completion
Secondary outcome [3] 346200 0
Muscular strength, as assessed by grip strength, chest press 1 rep-max estimate, and leg press 1 rep-max estimate (composite secondary outcome)
Timepoint [3] 346200 0
Baseline and 1 week post-intervention completion
Secondary outcome [4] 346201 0
Functional performance, as assessed by chair rise to standing test, 6 minute walk test, tandem balance, hamstring flexibility, and timed up and go test (composite secondary outcome)
Timepoint [4] 346201 0
Baseline and 1 week post-intervention completion

Eligibility
Key inclusion criteria
Patients with a histological diagnosis of prostate cancer and currently on androgen deprivation therapy
Willing to participate in the exercise program
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any musculoskeletal, cardiovascular or neurological condition or contraindication which would limit participation in the exercise program
Not able to read, write, speak and understand English (poor literacy skills)

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot study only. No sample size calculations were performed.

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment hospital [1] 10821 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 22561 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 299189 0
Commercial sector/Industry
Name [1] 299189 0
Astra Zeneca
Address [1] 299189 0
66 Talavera Road
Macquarie Park NSW 2113
Country [1] 299189 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Kwok (Principal Investigator)
Address
Toowoomba Hospital
154 Pechey St
South Toowoomba
QLD 4350
Country
Australia
Secondary sponsor category [1] 298452 0
Individual
Name [1] 298452 0
Dr Devang Desai (Chief Investigator)
Address [1] 298452 0
Toowoomba Hospital
154 Pechey St
South Toowoomba
QLD 4350
Country [1] 298452 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300114 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 300114 0
Level 5 Surgical Block
Toowoomba Hospital
Toowoomba QLD 4350
Ethics committee country [1] 300114 0
Australia
Date submitted for ethics approval [1] 300114 0
25/01/2018
Approval date [1] 300114 0
03/04/2018
Ethics approval number [1] 300114 0
HREC/18/QRDD/11

Summary
Brief summary
This study is assessing the impact of an exercise program on quality of life and physical function in prostate cancer patients being treated with hormone therapy.

Who is it for?
You may be eligible for this study if you have biopsy proven prostate cancer and are currently on hormone therapy i.e. androgen deprivation therapy.

Study details
All participants will undertake an exercise program consisting of 3 one-on-one sessions with an exercise physiologist, followed by 14 weeks of group training and home-based exercises. Participants will answer a number of questionnaires, perform a number of physical function tests, and have their body composition assessed using a body composition scan.

It is hoped this study will demonstrate the effectiveness of exercise in improving patient quality of life and daily function, particularly in patients from rural/regional settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82614 0
Dr Michael Kwok
Address 82614 0
Toowoomba Hospital
154 Pechey St
South Toowoomba
QLD 4350
Country 82614 0
Australia
Phone 82614 0
+61746166000
Fax 82614 0
Email 82614 0
michael.kwok@health.qld.gov.au
Contact person for public queries
Name 82615 0
Dr Michael Kwok
Address 82615 0
Toowoomba Hospital
154 Pechey St
South Toowoomba
QLD 4350
Country 82615 0
Australia
Phone 82615 0
+61746166000
Fax 82615 0
Email 82615 0
michael.kwok@health.qld.gov.au
Contact person for scientific queries
Name 82616 0
Dr Michael Kwok
Address 82616 0
Toowoomba Hospital
154 Pechey St
South Toowoomba
QLD 4350
Country 82616 0
Australia
Phone 82616 0
+61746166000
Fax 82616 0
Email 82616 0
michael.kwok@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable