Trial from ANZCTR


Trial ID ACTRN12610000691044
Trial Status: Registered
Date Submitted: 11/08/2010
Date Registered: 20/08/2010
Prospectively registered

Page 1

Public title Exercise intervention trial for prostate cancer patients commencing Lucrin treatment
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Lucrin immediate exercise pilot trial - The effect of an exercise intervention on quality of life in prostate cancer patients commencing Lucrin treatment
Update:
 
Reason:
 
Secondary ID [1] 252415 0
None
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Treatment: Other 256981 0
Update:
 
Reason:
 
Intervention Code:
Lifestyle 257058 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core
Questionnaire (EORTC QLQ-C30).
258956 0
Update:
 
Reason:
 
Timepoint: Baseline, post-intervention (12 weeks) and follow-up (24 weeks). 258956 0
Update:
 
Reason:
 
Secondary Outcome: Physical and muscle function: muscle strength assessed using one-repetition maximum tests, repeated chair rise and 400-m walk. 265125 0
Update:
 
Reason:
 
Timepoint: Baseline, post-intervention (12 weeks) and follow-up (24 weeks). 265125 0
Update:
 
Reason:
 
Secondary Outcome: 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. 265126 0
Update:
 
Reason:
 
Timepoint: Baseline, post-intervention (12 weeks) and follow-up (24 weeks). 265126 0
Update:
 
Reason:
 
Secondary Outcome: Psychological distress will be assessed using the The Brief Symptom Inventory-18 (BSI-18). 265132 0
Update:
 
Reason:
 
Timepoint: Baseline, post-intervention (12 weeks) and follow-up (24 weeks). 265132 0
Update:
 
Reason:
 

Page 5

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.
Update:
 
Reason:
 
Minimum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Males
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
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.
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Treatment
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Central randomisation by computer
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computerised sequence generation
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/10/2010
Update:
 
Reason:
 
Date of first participant enrolment 27/06/2011
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled 30/10/2012
Update:
 
Reason:
 
Target sample size 60
Update:
 
Reason:
 
Recruitment status Completed
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s) WA,VIC
Update:
 
Reason:
 
Postcode: 3121 3133 0
Update:
 
Reason:
 
Postcode: 3000 3134 0
Update:
 
Reason:
 
Postcode: 6000 - Perth 7845 0
Update:
 
Reason:
 
Postcode: 6230 - Bunbury 7846 0
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Commercial sector/Industry 257432 0
Update:
 
Reason:
 
Name: Abbott Australasia Pty Ltd 257432 0
Update:
 
Reason:
 
Address: Locked Bag 5016
Botany, NSW 1455
257432 0
Update:
 
Reason:
 
Country: Australia 257432 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: Edith Cowan University
Update:
 
Reason:
 
Address: 270 Joondalup Drive
Joondalup WA 6027
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: Individual 256662 0
Update:
 
Reason:
 
Name: Professor Robert Newton 256662 0
Update:
 
Reason:
 
Address: School of Exercise, Biomedical and Health Sciences
270 Joondalup Drive
Joondalup WA 6027
256662 0
Update:
 
Reason:
 
Country: Australia 256662 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Edith Cowan University Human Research Ethics Commitee 259452 0
Update:
 
Reason:
 
Address: Edith Cowan University
Research Ethics
270 Joondalup Drive
Joondalup, WA 6027
259452 0
Update:
 
Reason:
 
Country: Australia 259452 0
Update:
 
Reason:
 
Approval Date: 25/11/2009 259452 0
Update:
 
Reason:
 
Submitted Date: 259452 0
Update:
 
Reason:
 
HREC: 4646 NEWTON 259452 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
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.
Update:
 
Public Notes
Update:
 

Page 10

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

Contact person for scientific queries
Title: Dr
Update:
 
Reason:
 
5675 0
Name: Dr Prue Cormie
Update:
 
Reason:
 
5675 0
Address: Edith Cowan University Vario Health Institute 270 Joondalup Drive Joondalup, WA 6027
Update:
 
Reason:
 
5675 0
Country: Australia
Update:
 
5675 0
Reason:
 
Tel: +61 8 6304 3418
Update:
 
Reason:
 
5675 0
Fax:
Update:
 
Reason:
 
5675 0
Email: p.cormie@ecu.edu.au
Update:
 
Reason:
 
5675 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
23819 0
Name: Dr Prue Cormie
Update:
 
Reason:
 
23819 0
Address: Edith Cowan University Vario Health Institute 270 Joondalup Drive Joondalup, WA 6027
Update:
 
Reason:
 
23819 0
Country: Australia
Update:
 
23819 0
Reason:
 
Tel: +61 8 6304 3418
Update:
 
Reason:
 
23819 0
Fax:
Update:
 
Reason:
 
23819 0
Email: p.cormie@ecu.edu.au
Update:
 
Reason:
 
23819 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: