Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000847314
Ethics application status
Approved
Date submitted
30/05/2017
Date registered
8/06/2017
Date last updated
29/10/2021
Date data sharing statement initially provided
29/07/2019
Date results information initially provided
29/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of High Intensity Exercise on Cardiovascular Function in Men with Metastatic Castrate-Resistant Prostate Cancer (MCRPC): a sub study of GAP4-QLD INTense Exercise foR surVivAL among men with MCRPC (INTERVAL - MCRPC)
Scientific title
The Effects of High Intensity Exercise on Cardiovascular Function in Men with Metastatic Castrate-Resistant Prostate Cancer (MCRPC): a sub study of GAP4-QLD INTense Exercise foR surVivAL among men with MCRPC (INTERVAL - MCRPC)
Secondary ID [1] 292009 0
None
Universal Trial Number (UTN)
U1111-1212-2514
Trial acronym
GAP4-QLD SUB UQ
Linked study record
NCT02730338

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castrate-Resistant Prostate Cancer (MCRPC) 303397 0
Condition category
Condition code
Cancer 302810 302810 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Men with Metastatic Castrate-resistant Prostate Cancer (MCRPC) who are receiving a tapered high-intensity exercise intervention plus psychosocial support will be observed for 24 months within the larger 'INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)' (Trial ID: NCT02730338) clinical trial. Changes in cardiovascular function will be observed and periodically tested within this 24-month period.

Participants randomised to the intervention arm within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338) will undertake 24 months of high intensity interval training. Participants will be required to complete three one-hour exercise sessions per week in either a university strength and conditioning gym or in the participant’s community/home. Each session will include a combination of high intensity aerobic and resistance exercises.

The exercise intervention will taper from fully supervised (month 1), to partially supervised (months 2-12) to fully self-managed (months 13-24). Supervised sessions will either be individual or group-based and will be supervised by an Accredited Exercise Physiologist (AEP). Participants will be provided with tailored exercise programs, designed by an AEP, for the duration of the intervention. These tailored exercise programs will be reviewed after each exercise session and will take into account each participant’s disease-status, exercise performance and exercise preferences. Programs will be delivered via a computer/phone application and thus can be accessed both at the gym and during self-managed sessions. Participants will be instructed on how to use the application during their first supervised training session.

Intervention participants will also receive psychosocial support, in the form of monthly newsletters, which will address prostate cancer-specific lifestyle factors/topics e.g. sexual health, dietary guidance.
Intervention code [1] 298141 0
Not applicable
Comparator / control treatment
Men with Metastatic Castrate-resistant Prostate Cancer (MCRPC) who are receiving psychosocial support alone will be observed for 24 months within the larger 'INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)' (Trial ID: NCT02730338) clinical trial. Changes in cardiovascular function will be observed and periodically tested within this 24-month period.

Men randomised to the control arm within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338) will receive 24 months of psychosocial support only. Psychosocial support will be provided in the form of monthly newsletters, which will address prostate cancer-specific lifestyle factors/topics e.g. sexual health, dietary guidance.

Participants who are screened through the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338) who do not wish to consent to participate in the clinical trial (hereafter referred to as Non-GAP4/NG4) and who are still eligible for the sub-study, will be invited to form an extension of the control group for the sub-study.
Control group
Active

Outcomes
Primary outcome [1] 302191 0
Changes in Brachial Artery Flow-mediated Dilation (FMD) as assessed via doppler ultrasound
Timepoint [1] 302191 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [1] 335137 0
Changes in Heart Rate Variability (HRV) as assessed via resting 3-lead ECG
Timepoint [1] 335137 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [2] 335138 0
Changes in Pulse Wave Analysis (PWA) as assessed via SphygmoCor® XCEL PWA and PWV system.
Timepoint [2] 335138 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [3] 335139 0
Changes in Pulse Wave Velocity (PWV) as assessed via SphygmoCor® XCEL PWA and PWV system.
Timepoint [3] 335139 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [4] 335140 0
Changes in oxidative stress as assessed via plasma nitrate and nitrite levels. Collected via 10mL Serum and 4mL Lith/Hep vacutainers.
Timepoint [4] 335140 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [5] 345539 0
Changes in vascular structure, as assessed via Carotid Intima-media Thickness (CIMT) using doppler ultrasound.
Timepoint [5] 345539 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [6] 345540 0
Changes in Autonomic Nervous System function, as assessed via heart rate and blood pressure responses to both deep breathing and a Valsalva Manoeuvre using a Finapres NOVA System.
Timepoint [6] 345540 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [7] 345541 0
Changes in prostate cancer cell growth, as assessed via cell culture analyses (using cell number assays and cell death assays). Collected via a 10mL Ethylenediaminetetraacetic acid (EDTA) vacutainer.
Timepoint [7] 345541 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [8] 345542 0
Changes in body composition, as assessed via whole-body bone, muscle and fat mass using Dual Energy X-ray Absorptiometry (DEXA).
Timepoint [8] 345542 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [9] 345543 0
Changes in body composition, as assessed via muscle cross sectional area and bone density of the tibia and femur using peripheral Quantitative Computed Tomography (pQCT).
Timepoint [9] 345543 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [10] 345544 0
Changes in habitual physical activity and sedentary behaviours, as assessed via accelerometery using a ActiGraph GT3X+ accelerometer
Timepoint [10] 345544 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [11] 345545 0
Changes in a hormonal blood marker, as assessed via levels of testosterone. Collected using a 10mL Ethylenediaminetetraacetic acid (EDTA) vacutainer.
Timepoint [11] 345545 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [12] 345546 0
Changes in metabolic and inflammatory blood markers, as assessed via levels of:
- Cardiac Troponin-I
- pro-Brain Natriuretic Peptide (pro-BNP)
- High-sensitivity C-reactive Protein (hs-CRP)
Collected using a 10mL Ethylenediaminetetraacetic acid (EDTA) vacutainer.
Timepoint [12] 345546 0
Baseline, 3 months, 6 months, 12 months and 24 months after randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).
Secondary outcome [13] 350835 0
NG4 Participants ONLY: Changes in health history/information and demographics, as assessed via a custom-designed survey.
Timepoint [13] 350835 0
Baseline, 3 months, 6 months, 12 months and 24 months after each NG4 participant's baseline Cardiopulmonary Exercise Test (CPET).
Secondary outcome [14] 350836 0
NG4 Participants ONLY: Diet standardisation for 24 hours prior to each NG4 testing session, as assessed via a 24-hour diet recall.
Timepoint [14] 350836 0
Baseline, 3 months, 6 months, 12 months and 24 months after each NG4 participant's baseline CPET.
Secondary outcome [15] 350837 0
NG4 Participants ONLY: Changes in habitual dietary intake, as assessed via a three-day diet diary.
Timepoint [15] 350837 0
Baseline, 3 months, 6 months, 12 months and 24 months after each NG4 participant's baseline CPET.
Secondary outcome [16] 350838 0
NG4 Participants ONLY: Changes in body composition, as assessed via:
- Weight
- Height
- Body mass index (BMI)
- Waist and hip circumferences
- Waist-to-hip ratio (WHR)
Timepoint [16] 350838 0
Baseline, 3 months, 6 months, 12 months and 24 months after each NG4 participant's baseline CPET.
Secondary outcome [17] 350839 0
NG4 Participants ONLY: Changes in cardiorespiratory fitness (VO2Peak), as assessed via a Cardiopulmonary Exercise Test (CPET) using a cycle ergometer and metabolic system.
Timepoint [17] 350839 0
Baseline, 3 months, 6 months, 12 months and 24 months after each NG4 participant's baseline CPET.

Eligibility
Key inclusion criteria
As participants for the sub-study will be recruited through the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338), the key inclusion criteria have been listed previously in INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL) (Trial ID: NCT02730338).

No additional key inclusion criteria are required to be met for involvement in this sub-study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
As participants for the sub-study will be recruited through the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338), the key exclusion criteria have been listed previously in INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL) (Trial ID: NCT02730338).

No additional key exclusion criteria are required to be met for involvement in this sub-study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
All participants in the sub-study will be recruited through the GAP4 INTERVAL clinical trial (Trail ID: Trial ID: NCT02730338). Approximately 60 participants randomised at a 1:1 ratio with Metastatic Castrate-Resistance Prostate Cancer will be recruited and allocated to the School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia site.

Therefore, the sample size for this sub-study has been defined as a convenience sample as the sub-study will be provided with a pre-determined number of possible participants. Similar sample sizes are also commonly used in studies which investigate differences in the primary outcome for this sub-study.

All raw data will be analysed via relevant software packages. Statistical analyses of raw data will be conducted on IBM SPPS Statistics for iOS. Analysis of normal distribution, within and between group differences over the five time points will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/06/2017
Actual
5/08/2017
Date of last participant enrolment
Anticipated
31/07/2020
Actual
10/10/2019
Date of last data collection
Anticipated
31/08/2022
Actual
25/01/2020
Sample size
Target
60
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 16139 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 296534 0
University
Name [1] 296534 0
University of Queensland
Country [1] 296534 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, QLD, 4072.
Country
Australia
Secondary sponsor category [1] 295488 0
None
Name [1] 295488 0
Address [1] 295488 0
Country [1] 295488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297754 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 297754 0
The University of Queensland, St Lucia, QLD, 4072
Ethics committee country [1] 297754 0
Australia
Date submitted for ethics approval [1] 297754 0
10/04/2017
Approval date [1] 297754 0
09/05/2017
Ethics approval number [1] 297754 0
2017000497

Summary
Brief summary
The purpose of this sub-study is to assess the effects of high intensity aerobic and resistance training plus psychosocial support on cardiovascular function in men with metastatic castrate-resistant prostate cancer (MCRPC).

Who is it for?
You may be eligible to participate in this sub-study if you are already enrolled in the GAP4 INTERVAL clinical trial (ClinicalTrials.gov ID: NCT02730338) in Queensland.

Study details
In addition to the requirements of the GAP4 INTERVAL clinical trial, all participants in this sub-study will be asked to attend assessment sessions at the University of Queensland at baseline, 3 months, 6 months, 12 months and 24 months after randomisation into the GAP4 INTERVAL trial. At each of these visits, various measures will be taken in order to assess cardiovascular function, including ultrasound and blood tests.

The findings of this sub-study will help in developing safe and effective lifestyle interventions which have the potential to lead to improved clinical practice for men with MCRPC.
Trial website
Trial related presentations / publications
Public notes
This sub-study is to be conducted alongside the larger 'INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)' (Trial ID: NCT02730338) clinical trial. For the purpose of this application, the clinical trail will be referred to as the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).

This sub-study is to be conducted at only one investigation site, the School of Human Movement and Nutrition Sciences, University of Queensland, St Lucia, Queensland, Australia, 4072. Participants will not be randomised within the sub-study itself, but will be eligible for enrolment once they have passed screening and randomisation within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338).

This sub-study is to include additional and seperate outcome measures (listed as primary and secondary outcomes within this application) to those being assessed within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338). These additional outcome measures will be assessed during 5 additional testing sessions within the GAP4 intervention/control period (12 months in total, with a follow-up at 24 months).
Attachments [1] 2591 2591 0 0
/AnzctrAttachments/372989-GAP4_Sub-Study_PICF_v3.0_22Oct2017.docx (Participant information/consent)
Attachments [2] 2999 2999 0 0
/AnzctrAttachments/372989-GAP4_Sub-Study_NG4_PICF_v1.0_22Oct2017.docx (Participant information/consent)

Contacts
Principal investigator
Name 75014 0
Miss Natalie Vear
Address 75014 0
School of Human Movement and Nutrition Sciences, Level 5, Human Movement Studies Building (26B), Blair Drive, University of Queensland, St Lucia, QLD, 4072
Country 75014 0
Australia
Phone 75014 0
+61 4 3490 4208
Fax 75014 0
Email 75014 0
[email protected]
Contact person for public queries
Name 75015 0
Prof Jeff Coombes
Address 75015 0
School of Human Movement and Nutrition Sciences, Level 5, Human Movement Studies Building (26B), Blair Drive, University of Queensland, St Lucia, QLD, 4072
Country 75015 0
Australia
Phone 75015 0
+61 7 3365 6767
Fax 75015 0
Email 75015 0
[email protected]
Contact person for scientific queries
Name 75016 0
Prof Jeff Coombes
Address 75016 0
School of Human Movement and Nutrition Sciences, Level 5, Human Movement Studies Building (26B), Blair Drive, University of Queensland, St Lucia, QLD, 4072
Country 75016 0
Australia
Phone 75016 0
+61 7 3365 6767
Fax 75016 0
Email 75016 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Nil as of yet.

Documents added automatically
No additional documents have been identified.