ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000690853

Ethics application status

Approved

Date submitted

25/03/2021

Date registered

7/06/2021

Date last updated

25/11/2022

Date data sharing statement initially provided

7/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of eccentric overload resistance exercise training on muscle mass and strength for people with prostate cancer and chemical castration

Scientific title

The effects of accentuated eccentric resistance training on muscle mass and strength in prostate cancer patients undergoing androgen-deprivation therapy

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate cancer

Lean muscle mass decline

Condition category

Condition code

Cancer

Prostate

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The participants will undergo 36 sessions of an accentuated eccentric resistance exercise training protocol planned for 3 × week for approximately 12 weeks. However, this will be tailored to the physical capacity of the participant, so the duration may be prolonged to 18 weeks in order for 36 sessions to be completed if the participant is only capable of performing 2 sessions per week.

The participants will perform circuits of 6 exercises (in their order of execution: abdominal crunch, seated row, chest press, lat pulldown, shoulder press, and leg press) using servomotor-driven resistance exercise machines (BioCircuit, TechnoGym, Italy). Before each training session, the participants will warm up by performing a circuit of 6 repetitions in each machine using ~50% of their prescribed resistance for the session.

The intensity of the concentric phase will be 40–80% of 1 repetition maximum (maximum weight that can be lifted with one repetition) while the eccentric phase will be 125% of the concentric load. Both the intensity and number of repetitions will vary during the trial. The repetitions will be split into 3 circuits. The time the participant takes to walk from one exercise station to another and assume the correct position will be used as an active rest period between exercises.

The resistance training sessions will be at least 48 h apart for each participant to allow for adequate recovery. All sessions will be conducted in small groups of one to five participants under direct supervision by exercise scientists to ensure safety and appropriate exercise technique.

A serving of 30 g of whey protein concentrate (Bulk Nutrients, Australia), containing 22.3 g of protein, 1.9 g of fat, and 2.8 g of carbohydrates, will be dissolved in 300 ml of water and given to the participants at the end of each exercise session. The participants will be asked to consume the drink in front of the investigator prior to leaving the facility. All participants will be informed about the allergens of the product (milk, soy, soybean, whey) prior to participation in the study.

Adherence to the exercise protocol will be assessed via assessing the adherence to the sessions (the ratio of the total number of training sessions attended to the number scheduled), while dosage will be assessed via calculating the volume prescribed vs performed (sets × repetition × weight(kg).

Whey protein will be asked to be consumed after each exercise session in the presence of the investigator, and the dosage will be 30 g (single serve) that will be given to the participant pre-mixed with water by the investigator.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

Pre- versus post-intervention, no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Whole-body lean mass (assessed through dual energy X-ray absorptiometry)

Timepoint [1]

1. Baseline
2. 4 days post-intervention completion

Primary outcome [2]

Muscle strength (Composite; maximum strength test for each exercise that will be performed during the training: abdominal crunch, seated row, chest press, lat pulldown, shoulder press, and leg press)

Timepoint [2]

1. Baseline
2. 4 days post-intervention completion

Primary outcome [3]

Knee extensor muscle area (composite; assessed through ultrasonography)

Timepoint [3]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [1]

Mid-thigh muscle area (through peripheral quantitative tomography)

Timepoint [1]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [2]

Postural balance (composite; assessed through NeuroCom Smart Balance Master, Natus Medical, USA).

Timepoint [2]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session
5. 4 days post-intervention completion

Secondary outcome [3]

Safety of the intervention (participant-reported adverse events)

Timepoint [3]

Any adverse events throughout the intervention will be reported (from the first familiarization session until 72 h after the post-training testing session.

Secondary outcome [4]

Exercise dosage (sets × repetition × weight(kg)) recorded by the exercise scientist.

Timepoint [4]

Dosage will be calculated after every training session (36 in total). Exercise dosage will be recorded by the exercise scientist during each session

Secondary outcome [5]

Muscle soreness (via a 0-100 mm VAS scale)

Timepoint [5]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [6]

Health-related quality of life (Functional Assessment of Cancer Therapy – Prostate, Version 4 (FACT-P))

Timepoint [6]

1. Baseline
2. Post-intervention

Secondary outcome [7]

Adherence to the intervention. Adherence will be calculated per participant by the ratio of the total number of training sessions attended to the number scheduled at the conclusion of the study, and reported cumulatively for all participants.

Timepoint [7]

Cumulative data will be assessed at the conclusion of the study

Secondary outcome [8]

Perception of fatigue (Functional Assessment of Chronic Illness Therapy – Fatigue, Version 4 (FACIT-F)

Timepoint [8]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [9]

Whole-body fat mass (primary outcome; assessed through dual energy X-ray absorptiometry)

Timepoint [9]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [10]

Whole-body bone mineral density, (primary outcome; assessed through dual energy X-ray absorptiometry)

Timepoint [10]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [11]

Mid-thigh fat area ( through peripheral quantitative tomography)

Timepoint [11]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [12]

Tumor necrosis factor a blood levels

Timepoint [12]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [13]

C-reactive protein blood levels

Timepoint [13]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [14]

interleukin 6 blood levels

Timepoint [14]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [15]

Low-density lipoprotein blood levels

Timepoint [15]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [16]

High-density lipoprotein blood levels

Timepoint [16]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [17]

tryglycerides blood levels

Timepoint [17]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [18]

cholesterol blood levels

Timepoint [18]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [19]

fructosamine blood levels

Timepoint [19]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [20]

creatine kinase blood levels

Timepoint [20]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [21]

insulin growth factor-1 blood levels

Timepoint [21]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [22]

growth hormone blood levels

Timepoint [22]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [23]

dehydroepiandrosterone blood levels

Timepoint [23]

1. Baseline
2. Immediately after the first exercise session
3. 24 h after the first exercise session
4. 48 h after the first exercise session

Secondary outcome [24]

Testosterone blood levels

Timepoint [24]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [25]

Prostate Specific Antigen blood levels

Timepoint [25]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [26]

400 m walk time (time to complete 400 meters walk) timed using a digital stopwatch

Timepoint [26]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [27]

30 second sit to stand test (how many times they can sit and stand from a chair in 30 seconds)

Timepoint [27]

1. Baseline
2. 4 days post-intervention completion

Secondary outcome [28]

Stair descend test (how fast they can descend 15 steps)

Timepoint [28]

1. Baseline
2. 4 days post-intervention completion

Eligibility

Key inclusion criteria

Men with prostate cancer undergoing androgen deprivation therapy

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will include absence of histologically documented prostate cancer; having undergone chemotherapy within the previous 6 months; not receiving ADT in the previous 3 months; not scheduled to receive ADT for the subsequent 4 months; any metastatic disease; any musculoskeletal, cardiovascular, or neurological disorder that could inhibit them from exercising; inability or unwillingness to undertake upper- and lower-limb exercise training; unwillingness or inability (lactose intolerance) to consume whey protein supplementation after each exercise session; and having performed resistance training in the previous 6 months.

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

Safety/efficacy

Statistical methods / analysis

A linear mixed-effects model will be used with participant ID as the random-effects factor. The assumption of normality and homoscedasticity of the residuals will be verified by visual quantile-quantile plot inspection of the plots and a Shapiro-Wilk test. In the case of a significant interaction effect, pairwise comparisons will be performed between conditions and timepoints, with a Holm’s P value adjustment. The criterion significance level will be set to P less than or equal to 0.05. All statistical testing will be performed using R (R Core Team) using the package lmerTest. Data will be presented as means (95% confidence intervals).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

18/06/2021

Actual

18/06/2021

Date of last participant enrolment

Anticipated

29/12/2023

Actual

Date of last data collection

Anticipated

30/06/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6027 - Joondalup

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Dr, Joondalup 6027, WA

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Dr, Joondalup 6027, WA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Edith Cowan University Human Research Ethics Committee

Ethics committee address [1]

270 Joondalup Dr, Joondalup 6027, WA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/01/2021

Approval date [1]

27/01/2021

Ethics approval number [1]

2020-02012-MAVROPALIAS

Summary

Brief summary

This trial aims to determine the effect of exercise training and whey protein supplementation on body composition, muscle strength, and blood markers of metabolism and inflammation in patients with prostate cancer undergoing androgen-deprivation therapy.

Who is it for?
You may be eligible for this study if you are aged 18 or above, have been diagnosed with prostate cancer, and are undergoing androgen deprivation therapy.

Study details
All participants will receive 36 sessions of resistance training, and 36 doses of whey protein supplementation over a total duration of 12 weeks. The resistance training will involve whole-body exercise using resistance training machines that overload the lowering phase of the repetitions. Before, during, and after the exercise program, participants will undergo body composition scans, have blood samples taken, perform a number of tests of muscle strength, and complete a series of questionnaires.

It is hoped that this study may demonstrate that the combination of exercise training and whey protein supplementation is effective in improving body composition, muscle strength, and blood markers of metabolism and inflammation in patients with prostate cancer receiving androgen deprivation therapy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Robert Newton

Address

Exercise Medicine Research Institute,
Edith Cowan University,
270 Joondalup Drive, Joondalup,
WA, 6027, Australia

Country

Australia

Phone

+61863043443

Fax

[email protected]

Contact person for public queries

Name

Dr Georgios Mavropalias

Address

Exercise Medicine Research Institute,
Edith Cowan University,
270 Joondalup Drive, Joondalup,
WA, 6027, Australia

Country

Australia

Phone

+61863046726

Fax

[email protected]

Contact person for scientific queries

Name

Dr Georgios Mavropalias

Address

Exercise Medicine Research Institute,
Edith Cowan University,
270 Joondalup Drive, Joondalup,
WA, 6027, Australia

Country

Australia

Phone

+61863046726

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11120	Study protocol			[email protected]		381662-(Uploaded-22-03-2021-17-44-48)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically