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Trial registered on ANZCTR


Registration number
ACTRN12620000432910
Ethics application status
Approved
Date submitted
17/03/2020
Date registered
1/04/2020
Date last updated
1/04/2020
Date data sharing statement initially provided
1/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise during radiotherapy on tumour oxygenation to improve treatment effectiveness in prostate cancer patients
Scientific title
Exercise as adjuvant therapy to increase prostate tumour oxygenation and improve effectiveness of radiotherapy
Secondary ID [1] 300702 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 316516 0
Condition category
Condition code
Cancer 314758 314758 0 0
Prostate
Physical Medicine / Rehabilitation 314909 314909 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be allocated to one of two groups, based on where they receive their radiotherapy treatment. Specifically, participants recruited from one site will only be allocated to an exercise group, whereas participants recruited from the other site will only be allocated to a standard care control group.

For participants in the exercise group, men with prostate cancer undergoing radiotherapy will attend three clinic-based supervised exercise sessions each week, for the duration of their radiotherapy treatment (6-8 weeks), consisting of moderate- to high-intensity aerobic and resistance exercise. The supervised exercise sessions will be scheduled immediately before radiotherapy sessions. Each exercise session will take approximately 20-30 minutes to complete and will be supervised face-to-face by an exercise physiologist with specific training in exercise for the management of cancer.

Participants will receive a progressive aerobic and lower limb resistance exercise program. Aerobic exercise will be performed at 60-85% of age-predicted maximal heart rate (i.e. 220-age) for 10-15 minutes per session on a motorised treadmill, stationary cycle ergometer (upright and recumbent), or performing box step-ups, followed by resistance exercise training. Resistance exercise will be prescribed using repetition maximums (RM), where patients will be required to perform 3-4 different resistance exercises using major muscle groups of the lower limbs, at 6-12 RM (the maximal weight that can be lifted 6 to 12 times each set, equivalent to ~70-85% of 1RM) for 1-2 sets per exercise to achieve moderate-to-high intensity. Lower limb resistance exercises will include wall squats, stiff-leg deadlifts, leg extensions, and leg curls.

To monitor exercise intensity, heart rate will be continuously recorded using a heart rate monitor with chest strap and blood pressure readings will be taken at rest and during the last minute of aerobic exercise as well as after leg extensions. In addition, exercise session intensity will be assessed with the Borg 10-point rating of perceived exertion scale. Exercise program adherence and compliance will be assessed through the use of attendance rates to supervised clinic sessions and percent of exercise session completed, specifically using exercise record sheets with prescribed programming variables to compare with actual versus completed components recorded.
Intervention code [1] 317023 0
Treatment: Other
Comparator / control treatment
Active control consisting of standard care, i.e. radiotherapy of 6-8 weeks, as indicated by the participant's radiation oncologist.
Control group
Active

Outcomes
Primary outcome [1] 323240 0
Tumour perfusion as assessed by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) [only assessed in the exercise group]
Timepoint [1] 323240 0
Baseline and 48 hours after baseline MRI
Primary outcome [2] 323241 0
Tumour hypoxia as assessed by serological analysis of hypoxia-inducible factor 1-alpha (HIF-1alpha)
Timepoint [2] 323241 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Primary outcome [3] 323298 0
Tumour hypoxia as assessed by serological analysis of carbonic anhydrase 9 (CAIX)
Timepoint [3] 323298 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [1] 381263 0
Feasibility as assessed by multiple indices including eligibility rate, recruitment rate, retention rate (i.e. trial completion), exercise adherence rate (calculated by dividing the number of attended training sessions by the number of planned training sessions), as well as exercise compliance (assessed by comparing prescribed versus actual completed exercise volume and intensity)
Timepoint [1] 381263 0
Assessed ongoing during the course of the intervention
Secondary outcome [2] 381264 0
Aerobic fitness as assessed by the 400m walk test
Timepoint [2] 381264 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [3] 381265 0
Lower body strength as assessed by the repeated sit-to-stand test
Timepoint [3] 381265 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [4] 381266 0
Mobility as assessed by the Timed Up and Go (TUG) test
Timepoint [4] 381266 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [5] 381267 0
Self-reported physical activity levels as assessed by the International Physical Activity Questionnaire (IPAQ; short form)
Timepoint [5] 381267 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [6] 381268 0
General health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30)
Timepoint [6] 381268 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [7] 381269 0
Cancer-related fatigue as assessed by the FACIT-Fatigue questionnaire
Timepoint [7] 381269 0
Baseline, after 4 weeks of radiotherapy, and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [8] 381270 0
Treatment-related urinary side effects as assessed by the International Prostate Symptom Score (I-PSS)
Timepoint [8] 381270 0
Baseline, after 4 weeks of radiotherapy, and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [9] 381271 0
White blood cell counts as assessed by flow cytometry
Timepoint [9] 381271 0
Second week of radiotherapy and last week of radiotherapy
Secondary outcome [10] 381273 0
Interleukin 6 as assessed by enzyme-linked immunosorbent assay (ELISA)
Timepoint [10] 381273 0
Second week of radiotherapy and last week of radiotherapy
Secondary outcome [11] 381475 0
Tumour angiogenesis as assessed by serological analysis of vascular endothelial growth factor (VEGF) [this is a primary outcome]
Timepoint [11] 381475 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [12] 381476 0
Prostate cancer-specific health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) prostate cancer-specific questionnaire (PR-25)
Timepoint [12] 381476 0
Baseline and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [13] 381477 0
Treatment-related bowel side effects as assessed by the Expanded Prostate Cancer Index Composite (EPIC; bowel domain only)
Timepoint [13] 381477 0
Baseline, after 4 weeks of radiotherapy, and following the completion of radiotherapy at 6-8 weeks
Secondary outcome [14] 381478 0
Cortisol as assessed by enzyme-linked immunosorbent assay (ELISA)
Timepoint [14] 381478 0
Second week of radiotherapy and last week of radiotherapy
Secondary outcome [15] 381479 0
Epinephrine as assessed by enzyme-linked immunosorbent assay (ELISA)
Timepoint [15] 381479 0
Second week of radiotherapy and last week of radiotherapy
Secondary outcome [16] 381480 0
Norepinephrine as assessed by enzyme-linked immunosorbent assay (ELISA)
Timepoint [16] 381480 0
Second week of radiotherapy and last week of radiotherapy
Secondary outcome [17] 381481 0
Exercise tolerance as assessed by recording sessional ratings of perceived exertion (Borg Scale, 0-10)
Timepoint [17] 381481 0
Assessed ongoing during the course of the intervention

Eligibility
Key inclusion criteria
Men diagnosed with localised prostate cancer who are scheduled to receive radiotherapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Previous or concomitant surgery or treatment for prostate cancer
(2) Stage IV metastatic cancer
(3) Contraindications to exercise training at moderate to vigorous intensity
(4) Baseline activity levels of >150 min/week at moderate to vigorous intensity
(5) Any uncontrolled medical condition
(6) Use of beta-adrenergic blocking agents
(7) Anaemia
(8) Body mass index (BMI) >30 kg/m2
(9) Currently smoking or quit smoking in the last six months
(10) Contraindication to magnetic resonance imaging or contrast agent (intervention arm only)
(11) Inability to walk 400 meters uninterrupted, unassisted, and pain-free

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16124 0
GenesisCare – Wembley - Wembley
Recruitment hospital [2] 16125 0
GenesisCare – Shenton House - Joondalup
Recruitment postcode(s) [1] 29643 0
6014 - Wembley
Recruitment postcode(s) [2] 29644 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 305145 0
University
Name [1] 305145 0
Edith Cowan University
Address [1] 305145 0
270 Joondalup Dr
Joondalup WA 6027
Country [1] 305145 0
Australia
Funding source category [2] 305253 0
Charities/Societies/Foundations
Name [2] 305253 0
Cancer Council Western Australia
Address [2] 305253 0
420 Bagot Rd
Subiaco WA 6008
Country [2] 305253 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 305503 0
None
Name [1] 305503 0
Address [1] 305503 0
Country [1] 305503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305512 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305512 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 305512 0
Australia
Date submitted for ethics approval [1] 305512 0
10/04/2019
Approval date [1] 305512 0
07/06/2019
Ethics approval number [1] 305512 0

Summary
Brief summary
The purpose of this project is to investigate the feasibility and preliminary efficacy of exercise to increase prostate tumour blood flow and oxygenation as a means to improve the effectiveness of radiotherapy.

Who is it for?
You may be eligible to join this study if you are a male aged 18 years or over, have a diagnosis of localised prostate cancer, and are scheduled to receive radiotherapy.

Study details:
Participants in this study will be allocated to one of two groups, based on where they receive their radiotherapy treatment. Participants in one group will receive a supervised exercise intervention for the duration of their radiotherapy treatment (6-8 weeks), while participants in the other group will receive usual medical care and be offered the exercise program upon completion of their radiotherapy treatment. The exercise program involves aerobic and resistance exercises undertaken 3 times per week in an exercise clinic setting. The exercise sessions are 20-30 minutes in duration and take place immediately before radiotherapy treatment sessions.

All participants will complete assessments at baseline (i.e. before starting radiotherapy) and after completion of their radiotherapy treatment in order to evaluate tumour oxygenation, treatment side effects, aerobic fitness and functional capacity, as well as health-related quality of life. Additionally, participants in the immediate exercise group will undergo further assessments to evaluate tumour blood flow and immune cell mobilisation in response to single exercise sessions.

It is hoped that exercise will be found to be feasible during radiotherapy treatment for prostate cancer patients and that this research will contribute important new information that will be useful to clinicians in the management of prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100626 0
Mr Oliver Schumacher
Address 100626 0
Exercise Medicine Research Institute
Building 21, Level 2
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 100626 0
Australia
Phone 100626 0
+61 8 6304 3444
Fax 100626 0
Email 100626 0
o.schumacher@ecu.edu.au
Contact person for public queries
Name 100627 0
Mr Oliver Schumacher
Address 100627 0
Exercise Medicine Research Institute
Building 21, Level 2
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 100627 0
Australia
Phone 100627 0
+61 8 6304 3444
Fax 100627 0
Email 100627 0
o.schumacher@ecu.edu.au
Contact person for scientific queries
Name 100628 0
Mr Oliver Schumacher
Address 100628 0
Exercise Medicine Research Institute
Building 21, Level 2
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 100628 0
Australia
Phone 100628 0
+61 8 6304 3444
Fax 100628 0
Email 100628 0
o.schumacher@ecu.edu.au

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 other documents available
Summary results
No Results