Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000099123
Ethics application status
Approved
Date submitted
21/01/2019
Date registered
23/01/2019
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of creatine supplementation and weight training on muscle mass in individuals with prostate cancer undergoing androgen deprivation therapy.
Scientific title
Examining the effect of creatine supplementation in augmenting adaptations to resistance training in prostate cancer patients undergoing androgen deprivation therapy: a randomized, double-blind, placebo controlled trial.
Secondary ID [1] 297135 0
None
Universal Trial Number (UTN)
Trial acronym
ProCreat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 311197 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309817 309817 0 0
Other physical medicine / rehabilitation
Cancer 309843 309843 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Design
This is a double-blind randomised controlled trial designed to measure the effects of creatine (Cr) supplementation in addition to resistance training (RT) in prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT). Both supplement (SUPP) and control (PLA) groups will receive a 12-week supervised exercise program comprising of RT undertaken three times per week. In addition, participants in the SUPP group will receive a daily dose of Cr: 20 g/day during the loading phase, 5g/d thereafter for the duration of the study. The PLA group will also receive a daily dose of a placebo of dextrose (following the same dosing protocol as SUPP).

Participants
Fifty-six men (n=56) with localised or locally advanced prostate cancer, who are currently on ADT (and expected to remain on ADT for the next three months) will be eligible to enrol in this study.

Exercise Program
Participants assigned to each arm will attend three (60-minute) clinic-based supervised RT sessions each week, for 12 weeks. RT will be prescribed using repetition maximums (RM), where participants will be required to perform 8 different exercises using major muscle groups (Chest press, Push Up, Seated Row, Shoulder Press, Lat Pulldown, Leg Press, Step Up, Leg Curl) at 8-12 RM (the maximal weight that can be lifted 8 to 12 times each set, equivalent to ~65-85% of 1RM) for 3-4 sets per exercise. Accredited Exercise Physiologists will supervise all exercise sessions.


Supplement & Placebo protocol
Participants in the SUPP group will receive 20g/day of Cr monohydrate for five days, divided into four equal doses throughout the day in the week prior to the start of the 12-week training program. Participants will then be given single daily doses of 5 grams for the remaining 12 weeks in the study. Participants in the PLA group will follow the same dosing protocol with dextrose. Participants will be asked to dissolve the supplements in 200-300 mL juice to mask the solubility of Cr and taste of dextrose. To increase compliance, participants will be asked to return empty packets to the research team once a week. Supplement packages will be coded so that neither the investigators nor the participants will be aware of contents. Supplementation with Cr or PLA will begin following baseline assessments.
Intervention code [1] 313425 0
Lifestyle
Intervention code [2] 313426 0
Rehabilitation
Comparator / control treatment
The active "control" group will receive the exact same exercise program as those in the SUPP group. Additionally, participants in the control group will receive a placebo of 20g/day of dextrose for five days, divided into four equal doses throughout the day. Participants will then be given single daily doses of 5 grams for the remainder of the study. Participants will be asked to dissolve the supplements in 200-300 mL juice to mask the taste of dextrose.
Control group
Active

Outcomes
Primary outcome [1] 318778 0
Body Composition using a whole body Dual-energy X-ray Absorptiometry (DXA; Horizon A, Hologic Inc., Massachusetts, USA) scan. Mid thigh and upper arm will be measured using peripheral Quantitative Computed Tomography (pQCT; XCT-3000, Stratec, Pzochienheim, Germany).
Timepoint [1] 318778 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [1] 366004 0
Muscle Strength - 1 RM Chest Press
Timepoint [1] 366004 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [2] 366005 0
Quality of Life - SF-36
Timepoint [2] 366005 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [3] 366006 0
Cancer-Related Fatigue (FACIT fatigue scale)
Timepoint [3] 366006 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [4] 366007 0
Blood biomarker - Creatinine
Timepoint [4] 366007 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [5] 366011 0
Physical Function - 30-second chair stand
Timepoint [5] 366011 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [6] 366068 0
Muscle Strength 1 RM Leg Press
Timepoint [6] 366068 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [7] 366069 0
Muscle Strength 1 RM Seated Row
Timepoint [7] 366069 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [8] 366070 0
Physical Function - Timed Up and Go
Timepoint [8] 366070 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [9] 366071 0
Physical Function 400 metre walk test
Timepoint [9] 366071 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [10] 366072 0
Blood biomarkers - Cystatin - C
Timepoint [10] 366072 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [11] 366073 0
Quality of Life - EORTC-QLQ-C30
Timepoint [11] 366073 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [12] 366074 0
Quality of Life - EORTC-PR-25
Timepoint [12] 366074 0
0-weeks (baseline) and 12-weeks post baseline.
Secondary outcome [13] 366075 0
Quality of Life - FACT-P
Timepoint [13] 366075 0
0-weeks (baseline) and 12-weeks post baseline.

Eligibility
Key inclusion criteria
Men with localised or locally advanced prostate cancer, who are currently on ADT (and expected to remain on ADT for the next three months) will be eligible to enrol in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have any visceral or bone metastases (i.e. advanced, or castrate-resistant prostate cancer); are being treated for any secondary or other cancers.

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)
Allocation will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated in a ratio of 1:1 to either supplement or placebo group using computer sequenced generation, stratified by age (=<60 years, >60 years) and time on ADT (=<6 months, >6 months), .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve 80% power at an alpha-level of .05 (two tailed), 25 participants per group would be required to detect a mean difference in change between the 2 groups for whole body lean mass of 1 kg (standard deviation of 1.25 kg) at the end of the 12-week intervention. This was based on a number of reports showing marked reductions in muscle mass in patients with prostate cancer undergoing ADT,2,20 which leads to muscle strength loss, functional limitations and mortality.21 Hence, we strongly believe that attenuation/reversal of ADT-induced muscle loss following our intervention is clinically meaningful. To account for attrition rate of ~10% seen in prior trials, we aim to recruit 56 participants (SUPP n=28; PLA n=28)

Summary descriptive statistics for participants’ characteristics for categorical variables and means±SDs or median and interquartile range (IQR) for continuous variables. Separate 2 (Condition: SUPP, PL) x 2 (baseline, follow-up) repeated-measures analyses of variance (ANOVAs) or analyses of covariance (ANCOVA), where appropriate, will be performed for each endpoint. For categorical variables, Pearson X2 test will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/02/2019
Actual
Date of last participant enrolment
Anticipated
27/08/2020
Actual
Date of last data collection
Anticipated
29/12/2020
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12973 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 25451 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301694 0
Charities/Societies/Foundations
Name [1] 301694 0
Cancer Council of Western Australia
Country [1] 301694 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 301414 0
Individual
Name [1] 301414 0
Ciaran Fairman
Address [1] 301414 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive - Joondalup, WA, 6027
Country [1] 301414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302414 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 302414 0
Ethics committee country [1] 302414 0
Australia
Date submitted for ethics approval [1] 302414 0
22/11/2018
Approval date [1] 302414 0
08/01/2019
Ethics approval number [1] 302414 0
22243 FAIRMAN

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90162 0
Dr Ciaran Fairman
Address 90162 0
Exercise Medicine Research Institute
Edith Cowan University
Building 21, Room 222
270 Joondalup Drive, JOONDALUP
Perth, Western Australia, 6027
Country 90162 0
Australia
Phone 90162 0
+61452268416
Fax 90162 0
Email 90162 0
[email protected]
Contact person for public queries
Name 90163 0
Ciaran Fairman
Address 90163 0
Exercise Medicine Research Institute
Edith Cowan University
Building 21, Room 222
270 Joondalup Drive, JOONDALUP
Perth, Western Australia, 6027
Country 90163 0
Australia
Phone 90163 0
+61452268416
Fax 90163 0
Email 90163 0
[email protected]
Contact person for scientific queries
Name 90164 0
Ciaran Fairman
Address 90164 0
Exercise Medicine Research Institute
Edith Cowan University
Building 21, Room 222
270 Joondalup Drive, JOONDALUP
Perth, Western Australia, 6027
Country 90164 0
Australia
Phone 90164 0
+61452268416
Fax 90164 0
Email 90164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseExamining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: A randomised, double-blind, placebo-controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2019-030080
N.B. These documents automatically identified may not have been verified by the study sponsor.