Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy
| ISRCTN | ISRCTN88605738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88605738 |
| Secondary identifying numbers | STH 14639 |
- Submission date
- 23/08/2010
- Registration date
- 03/09/2010
- Last edited
- 17/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Derek Rosario
Scientific
Scientific
STH Teaching Hospitals
The University of Sheffield
School of Medicine and Biomedical Sciences
Academic Urology Unit
K Floor
Royal Hallamshire Hospital
Glossop Road
Sheffield
S11 7FE
United Kingdom
| d.j.rosario@sheffield.ac.uk |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a randomised control trial |
| 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. |
| Ethics approval(s) | 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) |
| Condition | Men with advanced prostate cancer receiving androgen suppression therapy |
| Intervention | A 12 week pragmatic, combined exercise and diet advice intervention (a "lifestyle" intervention) compared with usual clinical care controls. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 22/06/2007 |
| Overall study end date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Male |
| Target number of participants | 100 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 22/06/2007 |
| Recruitment end date | 01/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
STH Teaching Hospitals
Sheffield
S11 7FE
United Kingdom
S11 7FE
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Department
1st Floor
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom
| brenda.zinober@sth.nhs.uk | |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
University/education
Sheffield Hallam University (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | feasibility study results | 01/04/2011 | Yes | No | |
| Results article | results | 14/11/2012 | Yes | No | |
| Results article | results | 01/05/2014 | Yes | No |
