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

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN99048944
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/26948468 protocol 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28264695 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31699723 results (added 11/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Study Completion: 2016-08-01
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 108

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. As a feasibility trial, the dual primary outcomes will be randomisation rates and adherence to the intervention at six months following randomisation<br> 2. Randomisation rates will be calculated as the proportion of eligible men, who agree to be randomised<br> 3. Adherence to the intervention arms will be calculated independently for the two levels i.e. nutrition and physical activity<br> 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<br> 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<br>