Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001068550
Ethics application status
Approved
Date submitted
29/09/2015
Date registered
13/10/2015
Date last updated
22/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preliminary Efficacy of Implementing a Program of Exercise Medicine for Men on Prostate Cancer Active Surveillance - a Pilot Study
Scientific title
Preliminary Efficacy of Implementing a Program of Exercise Medicine for Men on Prostate Cancer Active Surveillance - a Pilot Study
Secondary ID [1] 287564 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 296345 0
Condition category
Condition code
Cancer 296621 296621 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Supervised resistance and aerobic exercise performed over 3 sessions per week (approx. 60 min per session) for 6 months. Resistance exercise involves 6-8 exercises that target the major upper and lower body muscle groups. Intensity is manipulated from 6-12 repetition maximum using 1-4 sets per exercise. The aerobic exercise component includes 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. The exercise sessions are conducted in small groups and under direct supervision by an accredited exercise physiologist. Participants are encouraged to undertake additional aerobic exercise outside the clinic sessions with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Exercise adherence is assessed by register of attendance at the exercise sessions and exercise diary for home exercises.

Usual care group: Unsupervised walking program and an educational booklet outlining the current national aerobic exercise recommendations for cancer survivors along with a log-book to record the physical activity. Patients are encouraged to achieving a total of at least 150 minutes of aerobic exercise per week by month 6.
Intervention code [1] 292966 0
Rehabilitation
Comparator / control treatment
Usual Care
Control group
Active

Outcomes
Primary outcome [1] 296234 0
Feasibility assessed by recruitment, retention and exercise adherence rates
Timepoint [1] 296234 0
Baseline, 3 months and 6 months after randomisation
Primary outcome [2] 296235 0
Muscle strength assessed by 1-RM for the leg press and chest press
Timepoint [2] 296235 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [1] 317907 0
Disease progression assessed by blood biomarkers (PSA, testosterone, insulin, C-peptide, IGF-1, IGFBP-1, Interleukin 6 (IL-6), TNFa, total cholesterol, HDL-C, LDL-C, triglycerides, CRP, MIF, caveolin-167-69, IQGAP145) and in cell culture (Ki-67, Caspase 3)
Timepoint [1] 317907 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [2] 317908 0
Epigenetic modulations in tumor competitive lymphocytes (NK-cells and CD8+ T-lymphocytes) assessed by immunocytochemistry
Timepoint [2] 317908 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [3] 317909 0
Anxiety assessed by the Latini Scale and the Memorial Anxiety Scale for Prostate Cancer
Timepoint [3] 317909 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [4] 317910 0
Cancer specific and psychological distress assessed by the Impact of Event Scale and the Brief Symptom Inventory-18
Timepoint [4] 317910 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [5] 317911 0
Physical function assessed by the 400m walk (aerobic capacity), the repeated chair rise (lower body muscle function) and the usual and fast pace 6m walk (ambulation)
Timepoint [5] 317911 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [6] 317912 0
Physical activity levels assessed by the modified Godin Leisure Time Exercise Questionnaire
Timepoint [6] 317912 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [7] 317913 0
Insomnia measured by the Insomnia Severity Index
Timepoint [7] 317913 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [8] 317914 0
Cognitive function assessed by the Verbal Fluency Test and the Trail Making Test
Timepoint [8] 317914 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [9] 317915 0
Body composition assessed by a whole body dual-energy X-ray absorptiometry scan
Timepoint [9] 317915 0
Baseline, 3 months and 6 months after randomisation
Secondary outcome [10] 317916 0
Muscle density assessed by a peripheral quantitative computed tomography
Timepoint [10] 317916 0
Baseline, 3 months and 6 months after randomisation

Eligibility
Key inclusion criteria
1) Be within 1 year of diagnosis of prostate cancer (clinical state as T1C and T2, Gleason score smaller than or equal to 6 (or as determined by treating clinician) and under 3 biopsy cores invaded with prostate cancer, PSA < 10ng/ml and PSA density < .2ng/ml) and undergoing active surveillance
2) Have physician consent
3) Willing to be randomised
4) Able to read and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Received former therapy for prostate cancer
2) Not fit for curative treatment
3) Already performing regular exercise defined as undertaking structured resistance and aerobic training two or more times per week within the past 3 months
4) Any acute illness, musculoskeletal, cardiovascular or neurological disorder that could inhibit a participant's ability to participate in the exercise program or put them at risk of injury or illness.

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
7/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292132 0
University
Name [1] 292132 0
Edith Cowan University
Country [1] 292132 0
Australia
Primary sponsor type
University
Name
Edith Cowan University Exercise Medicine Research Institute
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 290810 0
None
Name [1] 290810 0
Address [1] 290810 0
Country [1] 290810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293612 0
Human Research Ethics Committee
Ethics committee address [1] 293612 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Ethics committee country [1] 293612 0
Australia
Date submitted for ethics approval [1] 293612 0
01/04/2015
Approval date [1] 293612 0
05/05/2015
Ethics approval number [1] 293612 0
12550

Summary
Brief summary
The primary purpose of this study is to determine the feasibility and efficacy of an exercise program to ameliorate the primary physical and mental health problems faced by men on prostate cancer active surveillance and to explore potential mechanisms underlying the influence of phsical exercise on markers of disease progression.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer in the previous year, currently undergoing active surveillance.

Study details
Participants will be randomly allocated (by chance) to receive either the exercise program or usual care. Participants in the exercise program group will receive supervised resistance and aerobic exercise sessions, each lasting approximately one hour, three times per week for six months. These participants will also be encouraged to complete additional aerobic exercise at home to create a total of 150 minutes of moderate aerobic exercise per week. Participants allocated to receive usual care will be encouraged to complete a walking program and will be given an information booklet detailing the current national aerobic exercise recommendations for cancer survivors along with a log-book to record their physical activity. The aim will be to complete a total of 150 minutes of aerobic exercise per week by month 6.

Patient outcomes will then be assessed through blood samples, fitness tests and questionnaires at 3 months and 6 months.

It is hoped that the findings of this trial will provide information regarding the feasibility of implementing an exercise intervention for prostate cancer patients on active surveillance, as well as the efficacy of such a program on mental and physical health outcomes, as well as on disease progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60670 0
Prof Daniel Galvao
Address 60670 0
Edith Cowan University
Exercise Medicine Research Institute
270 Joondalup Drive
JO21.231
Joondalup WA 6027
Country 60670 0
Australia
Phone 60670 0
+61863043420
Fax 60670 0
Email 60670 0
[email protected]
Contact person for public queries
Name 60671 0
Dr Eva Zopf
Address 60671 0
Edith Cowan University
Exercise Medicine Research Institute
270 Joondalup Drive
JO21.223
Joondalup WA 6027
Country 60671 0
Australia
Phone 60671 0
+61863045476
Fax 60671 0
Email 60671 0
[email protected]
Contact person for scientific queries
Name 60672 0
Prof Daniel Galvao
Address 60672 0
Edith Cowan University
Exercise Medicine Research Institute
270 Joondalup Drive
JO21.231
Joondalup WA 6027
Country 60672 0
Australia
Phone 60672 0
+61863043420
Fax 60672 0
Email 60672 0
[email protected]

No information has been provided regarding IPD availability


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.