Nutrition and physical activity trial in prostate cancer patients

ISRCTN	ISRCTN75282423
DOI	https://doi.org/10.1186/ISRCTN75282423
Protocol serial number	N/A
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Queen's University Belfast (UK)

Submission date: 09/09/2009
Registration date: 08/10/2009
Last edited: 26/10/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-diet-exercise-hormone-therapy-prostate-cancer

Contact information

Dr Marie Cantwell
Scientific

Centre for Public Health
Queen's University Belfast
Mullhouse Building
Royal Victoria Hospital
Grosvenor Rd
Belfast
BT12 6BJ
United Kingdom

Phone	+44 28 90634800
Email	m.cantwell@qub.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	Prostate Nutrition Study
Study objectives	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(s)	Office for Research Ethics Committees Northern Ireland, approved on 21/05/2009 (ref: 09/NIR03/41)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	The feasibility of dietary and physical activity intervention will be assessed by drop-out and effectiveness of intervention at the end of intervention.
Completion date	01/07/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Male
Target sample size at registration	94
Total final enrolment	94
Key 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
Key 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
Date of first enrolment	06/08/2009
Date of final enrolment	01/07/2011

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Centre for Public Health

Belfast
BT12 6BJ
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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Protocol article	protocol	12/08/2010		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
28/09/2018: Publication reference added