Trial registered on ANZCTR


Trial ID
ACTRN12610000691044
Ethics application status
Approved
Date submitted
11/08/2010
Date registered
20/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise intervention trial for prostate cancer patients commencing Lucrin treatment
Scientific title
Lucrin immediate exercise pilot trial - The effect of an exercise intervention on quality of life in prostate cancer patients commencing Lucrin treatment
Secondary ID [1] 252415 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 257926 0
Condition category
Condition code
Cancer 258096 258096 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise: progressive supervised resistance exercises
(e.g. upper and lower body resistance based
exercise using weight machines) and aerobic exercise (e.g. walking, jogging, cycling, rowing etc.) twice weekly (60 minutes session) for 12 weeks. These sessions will be undertaken in small groups of participants (up to 6) and will be supervised by an Accredited Exercise Physiologist. Participants will continue their usual care for prostate cancer including treatment with the drug Lucrin for the duration of the intervention.
Intervention code [1] 256981 0
Treatment: Other
Intervention code [2] 257058 0
Lifestyle
Comparator / control treatment
Control: usual care delay exercise group. Participants in this group will receive usual care for 12 weeks then will receive the 12 week exercise intervention following the completion of the initial usual care period. Usual care will be determined on a case by case basis by the individual participants oncologists.
Control group
Active

Outcomes
Primary outcome [1] 258956 0
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core
Questionnaire (EORTC QLQ-C30).
Timepoint [1] 258956 0
Baseline, post-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [1] 265125 0
Physical and muscle function: muscle strength assessed using one-repetition maximum tests, repeated chair rise and 400-m walk.
Timepoint [1] 265125 0
Baseline, post-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [2] 265126 0
Body composition: Regional and whole body lean mass (including appendicular skeletal muscle mass) and fat mass will be derived from a dual energy X-ray absorptiometry (DXA) whole body scan. Additionally, body mass index (BMI) as well as waist and hip circumferences will be assessed.
Timepoint [2] 265126 0
Baseline, post-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [3] 265132 0
Psychological distress will be assessed using the The Brief Symptom Inventory-18 (BSI-18).
Timepoint [3] 265132 0
Baseline, post-intervention (12 weeks) and follow-up (24 weeks).

Eligibility
Key inclusion criteria
Prostate cancer patients initiating therapy with Lucrin and anticipate remaining so for the duration of the study, consent from physician and ability to undertake upper and lower body exercises.
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(1) bone metastatic disease, (2) musculoskeletal, cardiovascular, or neurological disorders that could inhibit participants from exercising, and/or (3) inability to undertake upper and lower limb exercise.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/10/2010
Actual date of first participant enrolment
27/06/2011
Anticipated date last participant enrolled
Actual date last participant enrolled
30/10/2012
Anticipated date of last data collection
Actual date of last data collection
Target sample size
60
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 3133 0
3121
Recruitment postcode(s) [2] 3134 0
3000
Recruitment postcode(s) [3] 7845 0
6000 - Perth
Recruitment postcode(s) [4] 7846 0
6230 - Bunbury

Funding & Sponsors
Funding source category [1] 257432 0
Commercial sector/Industry
Name [1] 257432 0
Abbott Australasia Pty Ltd
Address [1] 257432 0
Locked Bag 5016
Botany, NSW 1455
Country [1] 257432 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 256662 0
Individual
Name [1] 256662 0
Professor Robert Newton
Address [1] 256662 0
School of Exercise, Biomedical and Health Sciences
270 Joondalup Drive
Joondalup WA 6027
Country [1] 256662 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259452 0
Edith Cowan University Human Research Ethics Commitee
Ethics committee address [1] 259452 0
Edith Cowan University
Research Ethics
270 Joondalup Drive
Joondalup, WA 6027
Ethics committee country [1] 259452 0
Australia
Date submitted for ethics approval [1] 259452 0
Approval date [1] 259452 0
25/11/2009
Ethics approval number [1] 259452 0
4646 NEWTON

Summary
Brief summary
This study looks at the role of exercise in improving the quality of life in prostate cancer patients commencing treatment with the drug Lucrin.

Who is it for?
You can join this study if you are a man with prostate cancer which has not spread to distant sites (metastases) and you are about to begin therapy with the hormonal treatment Lucrin.

Trial details:
Participants will be divided into two groups. One group will take part in progressive supervised resistance & aerobic exercises (e.g. upper and lower body resistance-based exercise using weight machines as well as aerobic exercise including walking, jogging, cycling and rowing) twice weekly (60 minutes session) for 12 weeks. The second group will receive usual care only for 12 weeks and then will take part in the 12 week exercise program.

Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30). Physical and muscle function, body composition and psychological distress will also be assessed.
Trial website
Trial related presentations / publications
Publication:
Cormie, P., Galvao, D.A, Spry, N., Joseph, D., Chee, R., Taaffe, D.R., Chambers, S.K. and Newton, R.U. Can supervised exercise prevent treatment toxicity in prostate cancer patients initiating androgen deprivation therapy: A randomised controlled trial. British Journal of Urology International. 27 Jan 2014 [Epub ahead of print] doi: 10.1111/bju.12646.

Presentation:
Cormie, P., Galvao, D.A, Spry, N., Joseph, D., Chee, R., Taaffe, D.R., Chambers, S.K. and Newton, R.U. Can exercise prevent treatment toxicity in prostate cancer patients initiating androgen deprivation therapy: A randomised controlled trial. Urological Society of Australia and New Zealand Annual Scientific Meeting. Brisbane, QLD, March 2014.
Public notes

Contacts
Principal investigator
Name 31500 0
Prof Robert Newton
Address 31500 0
ECU Health and Wellness Institute
Edith Cowan University
270 Joondalup Drive, Joondalup, WA 6027
Country 31500 0
Australia
Phone 31500 0
+61 8 6304 5037
Fax 31500 0
Email 31500 0
r.newton@ecu.edu.au
Contact person for public queries
Name 14747 0
Dr Dr Prue Cormie
Address 14747 0
Edith Cowan University
Vario Health Institute
270 Joondalup Drive
Joondalup, WA 6027
Country 14747 0
Australia
Phone 14747 0
+61 8 6304 3418
Fax 14747 0
Email 14747 0
p.cormie@ecu.edu.au
Contact person for scientific queries
Name 5675 0
Dr Dr Prue Cormie
Address 5675 0
Edith Cowan University
Vario Health Institute
270 Joondalup Drive
Joondalup, WA 6027
Country 5675 0
Australia
Phone 5675 0
+61 8 6304 3418
Fax 5675 0
Email 5675 0
p.cormie@ecu.edu.au