Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000786594
Ethics application status
Approved
Date submitted
10/06/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise medicine to improve treatment outcomes for prostate cancer patients undergoing radiation therapy
Scientific title
Exercise medicine as adjunct therapy during RADIation for CAncer of the prostaTE to improve treatment efficacy – the ERADICATE study: a phase II randomised controlled trial
Secondary ID [1] 311953 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ERADICATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 333570 0
Condition category
Condition code
Cancer 330254 330254 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive a combined aerobic and resistance exercise program alongside usual care. The exercise program will be supervised by appropriately qualified exercise professionals (e.g., Exercise and Sports Science Australia accredited exercise physiologists) and will be delivered face to face, either individually or in small groups of up to 4 participants. Exercise sessions will be delivered 3 times per week (Monday, Wednesday, and Friday) for 4 to 8 weeks corresponding to the duration of a participant's radiotherapy treatment. Each exercise session will be 1 hour in duration, including a warm-up for 5 minutes and cool-down. Aerobic exercise (e.g., walking on a treadmill or cycling on a stationary ergometer) will be performed at an intensity of 65-85% of age-predicted maximal heart rate (calculated as 220–age [years]) for 15-20 minutes per session, followed by 30-35 minutes of resistance exercise per session. Resistance exercise will include 6-8 exercises that involve the major upper- and lower-body muscle groups. Each resistance exercise will be performed for 2-3 sets at a load of 8-12 repetitions per set (i.e., the maximum load with which 8-12 repetitions can be performed with correct form). The load will be increased by 5-10% when a participant can successfully complete 2 additional repetitions on the last set of an exercise for 2 consecutive sessions. The exercise program will be delivered at exercise clinics affiliated with Edith Cowan University or the Exercise Medicine Research Institute in the Perth metropolitan area. Intervention adherence will be assessed by the supervising exercise physiologist by recording the number of attended/missed exercise sessions as well as the actual amount of completed exercise (i.e., duration, intensity, and volume) at each session.
Intervention code [1] 328427 0
Treatment: Other
Intervention code [2] 328428 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive usual care. Usual care is defined as the standard medical treatment as determined by the treating radiation oncologist. Participants in the control group will be advised to maintain their usual activities during treatment, however, no exercise prescription or recommendation will be provided to them during this time. Following completion of their radiotherapy treatment, participants in the control group will undergo the identical exercise program as the intervention group for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 338493 0
Treatment response (as assessed by change in tumour apparent diffusion coefficient)
Timepoint [1] 338493 0
Baseline/pre radiotherapy, immediately post completion of radiotherapy (primary timepoint), and 3 months post completion of radiotherapy
Secondary outcome [1] 436131 0
Tumour perfusion
Timepoint [1] 436131 0
Baseline/pre radiotherapy and within 1 week after completion of radiotherapy
Secondary outcome [2] 436132 0
Tumour hypoxia
Timepoint [2] 436132 0
Baseline/pre radiotherapy and within 1 week after completion of radiotherapy
Secondary outcome [3] 436133 0
Prostate-specific antigen (PSA)
Timepoint [3] 436133 0
Baseline/pre radiotherapy, immediately post completion of radiotherapy, and 3 months post completion of radiotherapy
Secondary outcome [4] 436134 0
Health-related quality of life
Timepoint [4] 436134 0
Baseline/pre radiotherapy, after 4 weeks of radiotherapy, immediately post completion of radiotherapy, and 3 months post completion of radiotherapy
Secondary outcome [5] 436135 0
Treatment-related symptoms
Timepoint [5] 436135 0
Baseline/pre radiotherapy, after 4 weeks of radiotherapy, immediately post completion of radiotherapy, and 3 months post completion of radiotherapy
Secondary outcome [6] 436136 0
Fatigue
Timepoint [6] 436136 0
Baseline/pre radiotherapy, after 4 weeks of radiotherapy, immediately post completion of radiotherapy, and 3 months post completion of radiotherapy
Secondary outcome [7] 436137 0
Sleep quality
Timepoint [7] 436137 0
Baseline/pre radiotherapy, after 4 weeks of radiotherapy, immediately post completion of radiotherapy, and 3 months post completion of radiotherapy
Secondary outcome [8] 436138 0
Physical activity
Timepoint [8] 436138 0
Baseline/pre radiotherapy, after 4 weeks of radiotherapy, immediately post completion of radiotherapy, and 3 months post completion of radiotherapy
Secondary outcome [9] 436139 0
Cardiorespiratory fitness
Timepoint [9] 436139 0
Baseline/pre radiotherapy and within 1 week post completion of radiotherapy
Secondary outcome [10] 436140 0
Upper body muscle strength
Timepoint [10] 436140 0
Baseline/pre radiotherapy and within 1 week post completion of radiotherapy
Secondary outcome [11] 436141 0
Lower body muscle strength
Timepoint [11] 436141 0
Baseline/pre radiotherapy and within 1 week post completion of radiotherapy
Secondary outcome [12] 436142 0
Functional capacity
Timepoint [12] 436142 0
Baseline/pre radiotherapy and within 1 week post completion of radiotherapy
Secondary outcome [13] 436143 0
Mobility
Timepoint [13] 436143 0
Baseline/pre radiotherapy and within 1 week post completion of radiotherapy
Secondary outcome [14] 436144 0
Body composition, specifically whole body lean and adipose tissue mass, percent body fat, as well as appendicular skeletal muscle mass
Timepoint [14] 436144 0
Baseline/pre radiotherapy and within 1 week post completion of radiotherapy
Secondary outcome [15] 436145 0
Exercise adherence/compliance
Timepoint [15] 436145 0
Assessed after each exercise session throughout the intervention period
Secondary outcome [16] 436146 0
Safety
Timepoint [16] 436146 0
Assessed after each exercise session throughout the intervention period
Secondary outcome [17] 436148 0
Biochemical recurrence-free survival
Timepoint [17] 436148 0
2-year follow-up and 5-year follow-up post completion of radiotherapy
Secondary outcome [18] 436149 0
Progression-free survival
Timepoint [18] 436149 0
2-year follow-up and 5-year follow-up post completion of radiotherapy
Secondary outcome [19] 436150 0
Overall survival
Timepoint [19] 436150 0
2-year follow-up and 5-year follow-up post completion of radiotherapy

Eligibility
Key inclusion criteria
I) Patients diagnosed with localised or locally advanced prostate cancer;
II) Patients scheduled for conventional or moderately hypofractionated external beam radiotherapy; and
III) Approval from treating oncologist to participate in study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
I) Previous radical prostatectomy;
II) Patients already engaging in regular exercise (defined as undertaking structured, i.e. planned and individualised, aerobic or resistance exercise on 2 or more days per week within the past 3 months);
III) Acute illness or musculoskeletal/ cardiovascular/ neurological disorder that could put patients at risk during exercise testing or training;
IV) Bone metastases; and
V) Contraindication to magnetic resonance imaging.

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 performed through central randomisation by computer in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation table created with an online software application (Sealed Envelope). Allocation is stratified by planned radiotherapy treatment duration.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316292 0
Charities/Societies/Foundations
Name [1] 316292 0
World Cancer Research Fund International
Country [1] 316292 0
United Kingdom
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 318901 0
None
Name [1] 318901 0
Address [1] 318901 0
Country [1] 318901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315112 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 315112 0
Ethics committee country [1] 315112 0
Australia
Date submitted for ethics approval [1] 315112 0
Approval date [1] 315112 0
17/07/2023
Ethics approval number [1] 315112 0
2023-04149-SCHUMACHER

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

Contacts
Principal investigator
Name 133706 0
Prof Daniel Galvão
Address 133706 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 133706 0
Australia
Phone 133706 0
+61 8 6304 3420
Fax 133706 0
Email 133706 0
[email protected]
Contact person for public queries
Name 133707 0
Mrs Cailyn Walker
Address 133707 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 133707 0
Australia
Phone 133707 0
+61 8 6304 2307
Fax 133707 0
Email 133707 0
[email protected]
Contact person for scientific queries
Name 133708 0
Dr Oliver Schumacher
Address 133708 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 133708 0
Australia
Phone 133708 0
+61 8 6304 3444
Fax 133708 0
Email 133708 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
No additional documents have been identified.