Prostate Cancer Evidence of Exercise and Nutrition Trial: nutritional and physical activity interventions for men with localised prostate cancer - feasibility study

ISRCTN	ISRCTN99048944
DOI	https://doi.org/10.1186/ISRCTN99048944
Protocol serial number	Protocol Version 1.1, 13.08.2014
Sponsor	University of Bristol (UK)
Funders	National Institute for Health Research (NIHR) Bristol Nutritional Biomedical Research Unit based at University Hospitals Bristol NHS Foundation Trust (UK), University of Bristol (UK)

Submission date: 30/10/2014
Registration date: 17/11/2014
Last edited: 16/09/2021

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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-diet-and-exercise-after-surgery-for-prostate-cancer-prevent

Contact information

Dr Lucy Hackshaw-McGeagh
Scientific

Level 3, University Hospitals Bristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Study information

Primary study design	Interventional
Study design	Feasibility cohort study with a nested 2 x 3 factorial design open-label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The feasibility of a randomised controlled trial of dietary and physical activity interventions for men with localised prostate cancer: the PrEvENT trial
Study acronym	PrEvENT
Study objectives	This study aims to investigate the feasibility of recruiting and randomising men, diagnosed with localised prostate cancer who are to be treated with radical prostatectomy, into a cohort study and nested RCT of physical activity and nutrition modification
Ethics approval(s)	NRES Committee South West - Cornwall & Plymouth, 09/07/2014, ref: 14/SW/0056
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Participants will each be randomly allocated to one of two physical activity interventions, and one of three nutritional interventions. Men will be asked to follow their allocated interventions for six months. Physical activity interventions: 1. Brisk Walking - Walking at a brisk pace for 30 minutes, on at least 5 days a week, on top of your normal physical activity 2. Physical Activity Control - Carrying on with your normal levels of physical activity, if you request physical activity advice, standard, publically available, information will be provided as per usual care Nutritional interventions: 1. Lycopene Supplement Capsules - Taking one lycopene capsule daily (this will be provided) 2. Plant Based Diet - Eating as many portions of fruit and vegetables per day as you can, aiming for at least 5 daily portions. In addition, swapping dairy milk for non-dairy alternatives, for example soy milk, almond milk or rice milk, as often as you can 3. Nutrition Control - Carrying on with usual diet, if you request nutritional advice, standard, publically available, information will be provided as per usual care
Intervention type	Behavioural
Primary outcome measure(s)	1. As a feasibility trial, the dual primary outcomes will be randomisation rates and adherence to the intervention at six months following randomisation 2. Randomisation rates will be calculated as the proportion of eligible men, who agree to be randomised 3. Adherence to the intervention arms will be calculated independently for the two levels i.e. nutrition and physical activity 4. Adherence to the nutrition intervention will be assessed by analysis of mean serum, plasma or tissue levels, collected at cohort baseline, true trial baseline and 6 months post randomisation. Self-reported nutritional data will also be collected 5. Adherence to the physical activity intervention will be assessed via daily step count, recorded by pedometer and reported by the participants during the 6 month intervention phase. Self-reported physical activity data will also be collected
Key secondary outcome measure(s)	1. Intervention tolerability (qualitatively collected data, reporting of adverse events) 2. Trial retention (number of participants successfully followed-up at the end of the 6 month trial, as a proportion of those who we recruited to the trial and randomised into a study arm at the start of the trial) 3. Change in prostate specific antigen (PSA) level (Change in participants absolute PSA level, from randomisation to 6 month follow up, collected via blood sample) 4. Change in insulin-like growth factor I (IGF-I) (Change in participants IGF-I, from randomisation to 6 month follow up, collected via blood sample) 5. Change in general nutrition (self-reported at baseline, 3 and 6 months, food frequency questionnaire (FFQ), Willett et al, 1985) 6. Change in general physical activity levels (self-reported at baseline, 3 and 6 months, Recent Physical Activity Questionnaire, Besson et al, 2010, accelerometers worn for two one week periods at cohort baseline and 6 month follow up) 7. Acceptability and ease of use of accelerometer (self-reported) 8. Urinary symptoms (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, International Continence Society male - Short Form, (ICSmale-SF), Donovan et al., 2000) 9. Psychological factors (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, Profile of Mood States - Short Form (POMS-SF), McNair et al, 1992 and Benefit Finding Scale, Antoni, 2001) 10. Health beliefs (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, adapted from Prochaska & DiClemente, 1983; Ajzen, 1991) 11. Quality of life measures (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, (Functional Assessment of Cancer Therapy - Prostate) FACT-P, Cella, 1997) 12. General health data (collected at cohort baseline, true trial baseline, 3 and 6 month follow up) 13. Cancer related fatigue (collected at cohort baseline, true trial baseline, 3 and 6 month follow up, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Cella, 1997) 14. General lifestyle factors (Self-reported levels of smoking and drinking) 15. Weight, body mass index and body fat (nurse measured) 16. Attitudes and views of men and their spouses about nutrition and physical activity modification and participation in long term trials (Qualitatively collected data at 6 months follow up)
Completion date	01/08/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	150
Total final enrolment	108
Key inclusion criteria	1. Localised prostate cancer 2. To be undergoing radical prostatectomy 3. Be due to receive treatment at the Urology Centre, Southmead Hopsital, North Bristol NHS Trust 4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience 5. Be aged 18 or over, there is no upper age limit 6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level
Key exclusion criteria	1. Inability to give informed consent or unavailability for follow-up 2. Being identified as unsuitable to participate following guidance of their clinician 3. Co-morbidities which could prevent participation in the intervention (RCT only) ie. this could include uncontrolled congestive heart failure or angina, recent myocardial infarction or breathing difficulties requiring oxygen use or hospitalisation. Additionally, the use of a mobility aid other than a walking stick 4. Allergies which would prevent participation in the intervention (RCT only) ie. allergy to lycopene 5. Religious beliefs that constrain them from participating in any aspect of the intervention (RCT only) 6. Any other additional reason for not being able to participate in any aspect of the intervention (RCT only) 7. Current heavy consumers of the nutritional element of the intervention, as judged by the research team (RCT only) ie. those who have been taking lycopene supplements daily for more than three months or eat more than five portions of fruit and vegetables every single day 8. Those who routinely exercise vigorously may not be suitable for the intervention (RCT only)
Date of first enrolment	08/08/2014
Date of final enrolment	31/03/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University Hospitals Bristol Education Centre

Bristol
BS2 8AE
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/03/2017		Yes	No
Results article	results	06/11/2019	11/11/2019	Yes	No
Protocol article	protocol	07/03/2016		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/09/2021: Cancer Research UK lay results summary link added to Results (plain English).
11/11/2019: Publication reference and total final enrolment number added.
08/03/2016: Publication reference added.