Nutrition and physical activity trial in prostate cancer patients

ISRCTN ISRCTN75282423
DOI https://doi.org/10.1186/ISRCTN75282423
Secondary identifying numbers N/A
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 acronymProstate Nutrition Study
Study objectivesHypothesis 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) studiedProstate cancer patients receiving androgen deprivation therapy
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresThe feasibility of dietary and physical activity intervention will be assessed by drop-out and effectiveness of intervention at the end of intervention.
Overall study start date06/08/2009
Completion date01/07/2011

Eligibility

Participant type(s)Patient
Age groupOther
SexMale
Target number of participants94
Total final enrolment94
Key inclusion criteria1. 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 criteria1. 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 enrolment06/08/2009
Date of final enrolment01/07/2011

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Centre for Public Health
Belfast
BT12 6BJ
United Kingdom

Sponsor information

Belfast Health and Social Care Trust (UK)
Hospital/treatment centre

Knockbracken Healthcare Park
Saintfield Rd
Belfast
BT8 8BH
Northern Ireland
United Kingdom

Website http://www.belfasttrust.hscni.net/
ROR logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

University/education

Queen's University Belfast (UK)
Private sector organisation / Universities (academic only)
Alternative name(s)
QUB
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

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

Editorial Notes

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