Nutrition and physical activity trial in prostate cancer patients
ISRCTN | ISRCTN75282423 |
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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
Contact information
Dr Marie Cantwell
Scientific
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 |
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m.cantwell@qub.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 06/08/2009 |
Completion date | 01/07/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Other |
Sex | Male |
Target number of participants | 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
- Northern Ireland
- United Kingdom
Study participating centre
Centre for Public Health
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Knockbracken Healthcare Park
Saintfield Rd
Belfast
BT8 8BH
Northern Ireland
United Kingdom
Website | http://www.belfasttrust.hscni.net/ |
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https://ror.org/02tdmfk69 |
Funders
Funder type
University/education
Queen's University Belfast (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- QUB
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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? |
---|---|---|---|---|---|
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