Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol Version 1.1, 13.08.2014
Study information
Scientific title
The feasibility of a randomised controlled trial of dietary and physical activity interventions for men with localised prostate cancer: the PrEvENT trial
Acronym
PrEvENT
Study hypothesis
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
NRES Committee South West - Cornwall & Plymouth, 09/07/2014, ref: 14/SW/0056
Study design
Feasibility cohort study with a nested 2 x 3 factorial design open-label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
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
Secondary outcome measures
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)
Overall trial start date
01/08/2014
Overall trial end date
01/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
120 for the randomised controlled trial (150 for the cohort/pre-surgery phase)
Participant 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)
Recruitment start date
08/08/2014
Recruitment end date
31/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals Bristol Education Centre
Bristol
BS2 8AE
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) Bristol Nutritional Biomedical Research Unit based at University Hospitals Bristol NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Bristol (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
Basic results (scientific)
Publication list
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26948468
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28264695