Condition category
Cancer
Date applied
23/08/2010
Date assigned
03/09/2010
Last edited
17/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Derek Rosario

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STH 14639

Study information

Scientific title

Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a randomised control trial

Acronym

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

22/06/2007

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Male

Target number of participants

100

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

United Kingdom

Trial participating centre

STH Teaching Hospitals
Sheffield
S11 7FE
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Research Department
1st Floor
11 Broomfield Road
Sheffield
S10 2SE
United Kingdom
-
brenda.zinober@sth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Sheffield Hallam University (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24119318

Publication citations

  1. Feasibility study results

    Bourke L, Doll H, Crank H, Daley A, Rosario D, Saxton JM, Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a feasibility study., Cancer Epidemiol. Biomarkers Prev., 2011, 20, 4, 647-657, doi: 10.1158/1055-9965.EPI-10-1143.

  2. Results

    Bourke L, Sohanpal R, Nanton V, Crank H, Rosario DJ, Saxton JM, A qualitative study evaluating experiences of a lifestyle intervention in men with prostate cancer undergoing androgen suppression therapy., Trials, 2012, 13, 208, doi: 10.1186/1745-6215-13-208.

Additional files

Editorial Notes