Plain English Summary
http://www.cancerhelp.org.uk/trials/study-diet-exercise-hormone-therapy-prostate-cancer
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marie Cantwell
ORCID ID
Contact details
Centre for Public Health
Queen's University Belfast
Mullhouse Building
Royal Victoria Hospital
Grosvenor Rd
Belfast
BT12 6BJ
United Kingdom
+44 28 90634800
m.cantwell@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial to evaluate the efficacy of a 6 month dietary and physical activity intervention for prostate cancer patients receiving androgen deprivation therapy
Acronym
Prostate Nutrition Study
Study hypothesis
Hypothesis is that the diet and physical activity intervention will;
1. Prevent or reduce weight gain, and prevent or reduce the increase in body fat mass typically found in patients treated with androgen deprivation therapy compared to the controls
2. Improve fatigue scores for those in the intervention group compared to those in the control group
3. Improve quality of life scores for those in the intervention group compared to those in the control group
As of 01/03/2011 the anticipated end date for this trial has been updated from 30/09/2010 to 01/07/2011
Ethics approval
Office for Research Ethics Committees Northern Ireland, approved on 21/05/2009 (ref: 09/NIR03/41)
Study design
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 the contact details below to request a patient information sheet
Condition
Prostate cancer patients receiving androgen deprivation therapy
Intervention
The intervention will consist of two components, a dietary intervention and a moderate physical activity intervention.
Dietary modification: The intervention group will meet individually with a nutritionist to receive dietary advice based on their usual diet measured at baseline in order to encourage them to adopt a diet to meet current dietary guidelines listed below:
a. Eat 5 or more servings of vegetables and fruits per day
b. Reduce total fat intake 30%-35% of total energy, with <10% saturated fat intake
c. Limit polyunsaturated fat intake to 10% of daily total energy intake
d. Limit consumption of processed meats
e. Eat fibre-rich foods. Aim to consume 25 to 35g of fibre daily.
f. Limit alcohol intake 28 units/ week
g. Limit intake of foods high in salt and/or sugar
Moderate physical activity: Brisk walking at least 30 min per day, in addition to usual activities on 5 or more days of the week.
The control group will receive usual care only.
Details of Joint Sponsor:
Queens University Belfast
Research and Regional Services
Room 103, Lanyon North
Belfast, BT7 1NN
United Kingdom
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Body Composition: Anthropometric measurement at baseline, mid-time (3 months) and end (6 months)
2. Fatigue: Self administrated Fatigue Severity Scale (FSS) questionnaire at baseline, mid-time (3 months) and end (6 months)
3. Quality of life: Self administrated Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire at baseline, mid-time (3 months) and end (6 months)
Secondary outcome measures
The feasibility of dietary and physical activity intervention will be assessed by drop-out and effectiveness of intervention at the end of intervention.
Overall trial start date
06/08/2009
Overall trial end date
01/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven adenocarcinoma of prostate
2. Commencing Lutenising Hormone Releasing Hormone Agonist (LHRHa) therapy for at least 6 months OR already being treated with LHRHa and planned to continue for at least a further 6 months
3. No age limit
Participant type
Patient
Age group
Other
Gender
Male
Target number of participants
94
Participant exclusion criteria
1. Co-morbid condition that limits physical activity such as severe cardiac disease, recent myocardial infarction, severe asthma or breathlessness, uncontrolled hypertension (blood pressure >160/95 mm/Hg) or severe pain
2. Medical conditions that requires a reduced fruit and vegetable diet (e.g. kidney failure)
3. Life expectancy of less than 2 years
Recruitment start date
06/08/2009
Recruitment end date
01/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Public Health
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Knockbracken Healthcare Park
Saintfield Rd
Belfast
BT8 8BH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
Queen's University Belfast (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
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
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20704726
Publication citations
-
Protocol
Haseen F, Murray LJ, O'Neill RF, O'Sullivan JM, Cantwell MM, A randomised controlled trial to evaluate the efficacy of a 6 month dietary and physical activity intervention for prostate cancer patients receiving androgen deprivation therapy., Trials, 2010, 11, 86, doi: 10.1186/1745-6215-11-86.