Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy

ISRCTN	ISRCTN88605738
DOI	https://doi.org/10.1186/ISRCTN88605738
Protocol serial number	STH 14639
Sponsor	Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Funder	Sheffield Hallam University (UK)

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 of protocol

Not provided at time of registration

Contact information

Mr Derek Rosario
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

Email	d.j.rosario@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a randomised control trial
Study objectives	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)
Health condition(s) or problem(s) studied	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(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
Key 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.
Completion date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Male
Target sample size at registration	100
Key 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.
Key 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
Date of first enrolment	22/06/2007
Date of final enrolment	01/01/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

STH Teaching Hospitals

Sheffield
S11 7FE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes