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Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy
ISRCTN ISRCTN88605738
DOI 10.1186/ISRCTN88605738
ClinicalTrials.gov identifier
EudraCT number
Public title Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy
Scientific title Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a randomised control trial
Acronym N/A
Serial number at source STH 14639
Study hypothesis 1. Patients undergoing androgen suppression therapy (AST) randomised to a lifestyle intervention increase their total physical activity levels in comparison to a usual care control group over the period of the intervention and at six months of follow up.
2. Patients undergoing AST randomised to a pragmatic lifestyle intervention experience improvements in health-related outcomes in comparison to a usual care control group over the period of the intervention and at six months of follow up.
3. Patients undergoing AST randomised to a lifestyle intervention demonstrate improvements in biomarkers associated with disease progression in comparison to a usual care control group.

As of 03/05/2012, the following changes were made on the record.
Anticipated end date has been updated from 01/09/2009 to 01/01/2013.
Target number of participants has been updated from 50 to 100.
Lay summary Not provided at time of registration
Ethics approval Ethical approval and research governance approval for this study was granted by South Sheffield Research Ethics Committee and the Sheffield Teaching Hospitals research department on the 22nd of June 2007 (ref: 07/Q2305/3)
Study design Prospective randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Men with advanced prostate cancer receiving androgen suppression therapy
Participants - inclusion criteria 1. Histologically confirmed, non-localised prostate cancer (PCa)
2. Stable disease (stable prostate specific antigen [PSA])
3. Receiving Androgen suppression therapy (AST) for a minimum period of six months
4. A willingness to comply with the randomised allocation to intervention and willing to undertake the requirements of the allocated intervention. If allocated to the exercise intervention, willing to aim to achieve 80% compliance to the exercise intervention.
Participants - exclusion criteria 1. Participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 30 minutes three or more times per week in the previous six months)
2. Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers
3. Uncontrolled painful or unstable bone lesions
4. Less than two months post surgical treatment
5. Any physical, neurological or psychiatric impairment or disease such as dementia, multiple sclerosis, severe arthritis or other condition that would limit the ability to understand and complete the study exercises and complete the required questionnaires, recall and record of dietary information
Anticipated start date 22/06/2007
Anticipated end date 01/01/2013
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 100
Interventions A 12 week pragmatic, combined exercise and diet advice intervention (a "lifestyle" intervention) compared with usual clinical care controls.
Primary outcome measure(s) Current primary outcome measures as of 12/07/2013:
To be measured at baseline, 12 and 26 weeks:
1. Quality of life measured using the FACTP questionnaire
2. Diastolic blood pressure measured using an automated sphygmomanometer

Previous primary outcome measures:
1. Exercise behaviour measured using the Godin Leisure Score Index questionnaire at baseline, 12 weeks and 6 months of follow-up
2. Dietary intake measured using three day diet diaries over the intervention period
Secondary outcome measure(s) Current secondary outcome measures as of 12/07/2013:
To be measured at baseline, 12 and 26 weeks:
1. Fatigue measured using the FACT-F questionnaire
2. Aerobic exercise tolerance measured using the Bruce treadmill protocol
3. Body mass measured using balance beam scales
4. Systolic blood pressure measured using an automated sphygmomanometer
5. Exercise behaviour measured using the Godin leisure score index questionnaire and heart rate monitoring

To be measured at baseline and 12 weeks:
1. Dietary macro- and micro-nutrients measured using three-day diet diaries and Netwisp software
2. PSA measured using an immunoenzymatic assay
3. Serum lipid profile measured using an enzymatic colorimetric assay
4. Serum androgen profile measured using an electrochemiluminescence assay
5. Arterial health measured using flow-mediated dilatation

Previous secondary outcome measures:
1. Quality of life measured using the FACT-P questionnaire
2. Fatigue measured using the FACT-F questionnaire
3. Body Mass Index (BMI) and waist-to-hip ratio
4. Aerobic exercise tolerance measured using the Bruce treadmill protocol
5. Lower limb strength measured using isokinetic dynamometry
6. Functional capacity measured using the chair sit-to-stand test
Above outcomes measured at baseline, 12 weeks and at six months of follow-up.
7. Biomarkers associated with disease progression were assessed at baseline and after the intervention period.
Sources of funding Sheffield Hallam University (UK)
Trial website
Publications 1. 2011 feasibility study results in http://www.ncbi.nlm.nih.gov/pubmed/21335510
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23151126
Contact name Mr  Derek  Rosario
  Address STH Teaching Hospitals,
The University of Sheffield,
School of Medicine and Biomedical Sciences,
Academic Urology Unit,
K Floor,
Royal Hallamshire Hospital,
Glossop Road,
  City/town Sheffield
  Zip/Postcode S11 7FE
  Country United Kingdom
  Email d.j.rosario@sheffield.ac.uk
Sponsor Sheffield Teaching Hospitals NHS Foundation Trust (UK)
  Address Research Department
1st Floor
11 Broomfield Road
  City/town Sheffield
  Zip/Postcode S10 2SE
  Country United Kingdom
  Email brenda.zinober@sth.nhs.uk
Date applied 23/08/2010
Last edited 12/07/2013
Date ISRCTN assigned 03/09/2010
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