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Trial registered on ANZCTR


Registration number
ACTRN12619000143123
Ethics application status
Approved
Date submitted
24/01/2019
Date registered
30/01/2019
Date last updated
28/09/2022
Date data sharing statement initially provided
30/01/2019
Date results provided
28/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of exercise on Sexual function and CArdiovascular health in men with prostate cancer (ESCA) Study
Scientific title
Effects of exercise on Sexual function and CArdiovascular health in men with prostate cancer (ESCA) Study
Secondary ID [1] 296889 0
Nil known
Universal Trial Number (UTN)
U1111-1225-6675
Trial acronym
ESCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 310826 0
Sexual Function 310827 0
Cardiovascular Disease Risk 310828 0
Condition category
Condition code
Cancer 309501 309501 0 0
Prostate
Reproductive Health and Childbirth 309502 309502 0 0
Other reproductive health and childbirth disorders
Cardiovascular 309503 309503 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves two components. The first, an interventional study which will compare the effects of a 12-week exercise intervention to usual care in men who have, or who have previously had, prostate cancer. The second, a situational appraisal of this exercise intervention.

1. Exercise Intervention
The intervention will be a structured and individualised 12-week exercise program with the following components:
1) Participants will aim to complete 36 one-hour exercise sessions during this 12-week period (equating to three exercise sessions per week) in either a supervised gymnasium or in the participant’s community/home (if deemed the participant is able to safely and effectively complete their exercises unsupervised). If participants are unable to reach the target 36 sessions during these 12 weeks (i.e. they miss sessions due to excess treatment-related side effects), then they will be provided with the option of performing make-up sessions during this 12-week period (i.e. a participant may complete two sessions one week, then four sessions the following week). Alternatively, participants will be provided with the option of completing as many of the remaining sessions as possible during one additional week, making the intervention 13 weeks in duration (at most) for these participants.
2) Supervised exercise sessions will either be individual or group-based and be supervised by an accredited exercise physiologist (AEP). Unsupervised home-based exercise sessions will be individual.
3) The exercise intervention will taper from fully supervised (weeks 1-4) to partially supervised with self-managed sessions (weeks 5-12).
4) Each session will include a tailored exercise program, including a combination of high intensity aerobic and resistance exercises. 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. High-intensity exercise will be individualised to the participants’ cardiorespiratory fitness and closely monitored by the AEP.
5) Exercise programs will be delivered via a computer/phone application (Physitrack®) and thus can be accessed by participants both during their supervised and self-managed home-based sessions. Participants will be provided with coaching on how to use the phone application during their initial supervised exercise sessions. If participants are unwilling and/or unable to use the phone application, then a paper version of their exercise program will be provided, with the AEP then manually entering the participants completed exercises into Physitrack®.

2. Situational Appraisal
Princess Alexandra Hospital clinicians (medical oncologists, prostate cancer nurses, physiotherapists, and service managers) and intervention participants will be invited to attend focus groups. Participants will be required to attend one of two focus groups, lasting no longer than 90 minutes in duration. Participants will be asked questions regarding resource utilisation, the knowledge and skills needed to implement the intervention, as well as cultural and structure barriers and facilitators.
Intervention code [1] 313165 0
Treatment: Other
Intervention code [2] 313166 0
Prevention
Intervention code [3] 313167 0
Lifestyle
Comparator / control treatment
Men who have, or who have previously had, prostate cancer who are randomised to the control group will continue with usual care (i.e. continue with their usual course of hormone therapy, chemotherapy, etc.; or continue with their normal health care, if not actively undergoing treatment for prostate cancer). Control group participants will be informed that they are not prohibited from exercising during the study period.
Control group
Active

Outcomes
Primary outcome [1] 308464 0
Changes in erectile function and intercourse satisfaction (composite outcome), as assessed via the Abridged version of the International Index of Erectile Function (IIEF-5) questionnaire
Timepoint [1] 308464 0
Baseline and 12 weeks (primary timepoint) after randomisation
Secondary outcome [1] 355008 0
Changes in erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction (composite outcome), as assessed via the International Index of Erectile Function (IIEF) questionnaire
Timepoint [1] 355008 0
Baseline and 12 weeks after randomisation
Secondary outcome [2] 355012 0
Changes in macro vascular function, as assessed via Brachial-Artery Flow-mediated Dilation (BA-FMD) using doppler ultrasound
Timepoint [2] 355012 0
Baseline and 12 weeks after randomisation
Secondary outcome [3] 355013 0
Changes in Brain Blood Flow and Carotid Dilation, as assessed via carotid-artery flow-mediated dilation and neurovascular coupling using a doppler ultrasound and a Finapres NOVA System
Timepoint [3] 355013 0
Baseline and 12 weeks after randomisation
Secondary outcome [4] 355014 0
Changes in macro vascular structure, as assessed via Carotid Intima-media Thickness (CIMT) using doppler ultrasound
Timepoint [4] 355014 0
Baseline and 12 weeks after randomisation
Secondary outcome [5] 355015 0
Changes in macro vascular function, as assessed via Carotid Distensibility (CD) using a doppler ultrasound, a hand-held PowerLab tonometer connected to LabChart, and a Finapres NOVA System
Timepoint [5] 355015 0
Baseline and 12 weeks after randomisation
Secondary outcome [6] 355016 0
Changes in central blood pressures and pulse wave characteristics, as assessed via Pulse Wave Analysis (PWA) using a SphygmoCor XCEL PWA and PWV system
Timepoint [6] 355016 0
Baseline and 12 weeks after randomisation
Secondary outcome [7] 355017 0
Changes in central pulse transfer times, as assessed via Pulse Wave Velocity (PWV) using a SphygmoCor XCEL PWA and PWV system
Timepoint [7] 355017 0
Baseline and 12 weeks after randomisation
Secondary outcome [8] 355018 0
Changes in autonomic nervous system function, as assessed via Heart Rate Variability (HRV) using a resting 3-lead electrocardiogram
Timepoint [8] 355018 0
Baseline and 12 weeks after randomisation
Secondary outcome [9] 355019 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 [9] 355019 0
Baseline and 12 weeks after randomisation
Secondary outcome [10] 355020 0
Changes in inflammatory blood markers, as assessed via levels of:
- Cardiac Troponin-I
- pro-Brain Natriuretic Peptide (pro-BNP)
- High-sensitivity C-reactive Protein (hs-CRP)
All bloods for Secondary Outcomes numbered 10-15 collected via 10mL and 6mL serum tubes, a 10mL Ethylenediaminetetraacetic acid (EDTA) tube, a 4mL Lith/Hep tube, and a 2mL glucose tube (32mL in total)
Timepoint [10] 355020 0
Baseline and 12 weeks after randomisation
Secondary outcome [11] 355021 0
Changes in oxidative stress as assessed via plasma nitrate and nitrite levels.
All bloods for Secondary Outcomes numbered 10-15 collected via 10mL and 6mL serum tubes, a 10mL Ethylenediaminetetraacetic acid (EDTA) tube, a 4mL Lith/Hep tube, and a 2mL glucose tube (32mL in total)
Timepoint [11] 355021 0
Baseline and 12 weeks after randomisation
Secondary outcome [12] 355022 0
Changes in metabolic and hormonal blood markers as assessed via;
- Low-density lipoprotein (LDL)
- High-density lipoprotein (HDL)
- Total cholesterol (TC)
- Triglycerides (TG)
- Fasting glucose
- Haemoglobin A1c (HbA1c)
- Insulin
- Insulin-like growth factor 1 (IGF-1)
All bloods for Secondary Outcomes numbered 10-15 collected via 10mL and 6mL serum tubes, a 10mL Ethylenediaminetetraacetic acid (EDTA) tube, a 4mL Lith/Hep tube, and a 2mL glucose tube (32mL in total)
Timepoint [12] 355022 0
Baseline and 12 weeks after randomisation
Secondary outcome [13] 355023 0
Changes in cytokine blood markers as assessed via;
- Interleukin 1 beta (IL-1beta)
- Interleukin 6 (IL-6)
- Interleukin 2 (IL-2)
- Tumor Necrosis Factor alpha (TNFalpha)
All bloods for Secondary Outcomes numbered 10-15 collected via 10mL and 6mL serum tubes, a 10mL Ethylenediaminetetraacetic acid (EDTA) tube, a 4mL Lith/Hep tube, and a 2mL glucose tube (32mL in total)
Timepoint [13] 355023 0
Baseline and 12 weeks after randomisation
Secondary outcome [14] 355024 0
Changes in prostate cancer cell growth, as assessed via cell culture analyses (using cell number assays and cell death assays).
All bloods for Secondary Outcomes numbered 10-15 collected via 10mL and 6mL serum tubes, a 10mL Ethylenediaminetetraacetic acid (EDTA) tube, a 4mL Lith/Hep tube, and a 2mL glucose tube (32mL in total)
Timepoint [14] 355024 0
Baseline and 12 weeks after randomisation
Secondary outcome [15] 355025 0
Changes in a hormonal blood marker, as assessed via levels of testosterone.
All bloods for Secondary Outcomes numbered 10-15 collected via 10mL and 6mL serum tubes, a 10mL Ethylenediaminetetraacetic acid (EDTA) tube, a 4mL Lith/Hep tube, and a 2mL glucose tube (32mL in total)
Timepoint [15] 355025 0
Baseline and 12 weeks after randomisation
Secondary outcome [16] 355026 0
Changes in state and trait anxiety, as assessed via the Hospital Anxiety and Depression Scale (HADS) questionnaire
Timepoint [16] 355026 0
Baseline and 12 weeks after randomisation
Secondary outcome [17] 355027 0
Changes in fatigue, as assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale questionnaire
Timepoint [17] 355027 0
Baseline and 12 weeks after randomisation
Secondary outcome [18] 355028 0
Changes in participant's perceived performance status, as assessed via the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Timepoint [18] 355028 0
Baseline and 12 weeks after randomisation
Secondary outcome [19] 355029 0
Changes in cardiorespiratory fitness (VO2Peak), as assessed via a Cardiopulmonary Exercise Test (CPET) using a cycle ergometer and metabolic system
Timepoint [19] 355029 0
Baseline and 12 weeks after randomisation
Secondary outcome [20] 355030 0
Changes in body composition, as assessed via whole-body bone, muscle and fat mass using Dual Energy X-ray Absorptiometry (DEXA)
Timepoint [20] 355030 0
Baseline and 12 weeks after randomisation
Secondary outcome [21] 355031 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 [21] 355031 0
Baseline and 12 weeks after randomisation
Secondary outcome [22] 355032 0
Changes in habitual physical activity and sedentary behaviours, as assessed via accelerometery using a ActiGraph GT3X+ accelerometer
Timepoint [22] 355032 0
Baseline and 12 weeks after randomisation
Secondary outcome [23] 355033 0
Adverse Events (AE) occurrence during the intervention period, as assessed via weekly face-to-face contact (at exercise sessions) from baseline to week 12. AE which might be directly related to the intervention (to be determined by an accredited exercise physiologist) will be assessed using the US Department of Health and Human Services Common Terminology Criteria for Adverse Events (CTCAE). Possible AE include:
- Cardiac events (e.g. Myocardial Infarction, Stroke, Cardiac Arrhythmia)
- Musculoskeletal events (e.g. Development of Lower Back Pain, Knee Pain)
- Treatment-related events (e.g. Fatigue development, Immunocompromised i.e. flu)
- Concurrent prostate cancer treatment-related events (e.g. Pain, Skin irritation)
Timepoint [23] 355033 0
Every supervised exercise session from baseline to week 12, throughout the 12-week exercise intervention period
Secondary outcome [24] 355034 0
Resource utilisation in both groups during the intervention period, as assessed via discussion in the situational appraisal component of the study. Discussion of labour (e.g. to deliver the intervention) and non-labour (e.g. gymnasium use, pain medication) costs. Resource use will be costed at market rates (e.g. industrial award rates for labour costs), for use in cost-effectiveness analyses.
Timepoint [24] 355034 0
Following exercise intervention completion
Secondary outcome [25] 355035 0
Evaluation of factors relating to participant adherence to the exercise intervention, as assessed via a Cancer Exercise Adherence Survey specially designed for this study
Timepoint [25] 355035 0
Baseline (Intervention group ONLY)
Secondary outcome [26] 355038 0
Changes in habitual dietary intake, as assessed via a three-day diet diary
Timepoint [26] 355038 0
Baseline and 12 weeks after randomisation
Secondary outcome [27] 355039 0
Changes in body composition, as assessed via:
- Weight
- Height
- Body mass index (BMI)
- Waist and hip circumferences
- Waist-to-hip ratio (WHR)
Timepoint [27] 355039 0
Baseline and 12 weeks after randomisation

Eligibility
Key inclusion criteria
- Men with a histologically-confirmed diagnosis of prostate cancer
- Sexual dysfunction score of moderate (score = 8-11/25), mild-to-moderate (score = 12-16/25), or mild (score = 17-21/25), as assessed by the abridged version of the International Index of Erectile Function (IIEF-5)
- Undergoing watchful waiting, active surveillance, or previous or concurrent treatment with any anti-cancer treatment/s
- Aged >18 years
- >4 weeks since major surgery
- No co-morbid condition or falls risk that could prevent safe completion of the intervention
- Cognitively capable of consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Planning to undergo surgery during the intervention period
- Any intellectual or physical disability which would make exercise intervention participation unsafe for the individual

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 is concealed at baseline. The randomisation process for this trial is performed by a person external to the study (an academic from The University of Queensland, St Lucia). A Chief Investigator for the trial then contacts the external person, who informs them of the participant’s randomisation at the conclusion of baseline testing sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals who consent to participate in the trial are randomised at a 1:1 ratio to either the intervention or control group by the external person. Randomisation is performed electronically online using permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
40 participants are required for >80% power to detect a clinically important mean difference of 6.1 points between groups at any assessment on the primary outcome (IIEF-5). This assumes up to 30% attrition, SD=5.5 and alpha=0.05. 

Statistical analyses of raw data will be conducted on IBM SPPS Statistics for iOS. Categorical outcomes will be described using frequencies and proportions, and analysed using general estimating equations with a logistic regression model to account for repeated measures. ORs and 95% CIs will be reported. Control and intervention groups will be compared for continuous outcomes using mean/SD or median/interquartile range if not normally distributed. To account for the repeated measures, continuous outcome measures will be modelled using linear mixed-models. Assumptions of models will be examined by plotting the residuals using histograms and skewness and kurtosis measures. If the data do not meet assumptions, the 95% CIs will be bootstrapped to provide reliable estimates. Models will only be adjusted for characteristics that were unbalanced between groups and related to the outcome variable.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
4/02/2019
Actual
14/03/2019
Date of last participant enrolment
Anticipated
22/09/2023
Actual
22/01/2020
Date of last data collection
Anticipated
22/12/2023
Actual
25/05/2020
Sample size
Target
40
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12729 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 25159 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 301461 0
University
Name [1] 301461 0
The University of Queensland
Country [1] 301461 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, QLD, 4072
Country
Australia
Secondary sponsor category [1] 301152 0
None
Name [1] 301152 0
Address [1] 301152 0
Country [1] 301152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302195 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 302195 0
Ethics committee country [1] 302195 0
Australia
Date submitted for ethics approval [1] 302195 0
14/11/2018
Approval date [1] 302195 0
11/01/2019
Ethics approval number [1] 302195 0
HREC/2018/QMS/47119

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

Contacts
Principal investigator
Name 89438 0
Dr Tina Skinner
Address 89438 0
Senior Lecturer in Exercise Physiology
School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus, Queensland, 4072
Country 89438 0
Australia
Phone 89438 0
+61 7 3346 8810
Fax 89438 0
Email 89438 0
[email protected]
Contact person for public queries
Name 89439 0
Natalie Vear
Address 89439 0
PhD Candidate
School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus, Queensland, 4072
Country 89439 0
Australia
Phone 89439 0
+61 4 7355 0978
Fax 89439 0
Email 89439 0
[email protected]
Contact person for scientific queries
Name 89440 0
Tina Skinner
Address 89440 0
Senior Lecturer in Exercise Physiology
School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus, Queensland, 4072
Country 89440 0
Australia
Phone 89440 0
+61 7 3346 8810
Fax 89440 0
Email 89440 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
As this is not a funded project and is part of a PhD student's work, we anticipate that the individual participants' data will not be made available on a publicly available repository. Should funding become available, or a journal request that the data be made available, we will apply for an amendment to make individual participant data available.


What supporting documents are/will be available?




Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.