Lycopene or Green Tea for Men at Risk of Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: Tomato rich dietBehavioral: Green tea drinkOther: Lycopene placebo capsulesDietary Supplement: green tea capsulesOther: Green tea placebo capsulesDietary Supplement: Lycopene capsules
- Registration Number
- NCT01105338
- Lead Sponsor
- University of Bristol
- Brief Summary
RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or green tea may be more effective in preventing prostate cancer.
PURPOSE: This randomized phase II trial is studying lycopene to see how well it works compared with green tea in preventing prostate cancer in patients previously enrolled in the ProtecT trial
- Detailed Description
OBJECTIVES:
Primary
* To assess serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization in patients with prostate cancer previously enrolled on ProtecT
Secondary
* To evaluate trial recruitment and randomization rates of patients treated with this regimen.
* To evaluate intervention tolerability in patients treated with this regimen.
* To evaluate compliance of patients treated with this regimen.
* To evaluate trial retention of patients treated with this regimen.
* To assess PSA values in patients treated with this regimen.
* To evaluate dietary compliance with recommendations of patients treated with this regimen.
* To assess weight and body mass index of patients treated with this regimen.
* To evaluate attitudes and views of men and their spouses about dietary modification and participation in long-term study.
OUTLINE: Patients are stratified according to PSA test levels obtained from ProtecT study recruitment clinic (\< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2 treatment arms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 126
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Tomato rich diet Tomato rich diet Tomato rich diet Green tea drink Green tea drink Green tea drink Lycopene placebo capsules Lycopene placebo capsules Lycopene placebo capsules Green tea capsules green tea capsules Green tea capsules Green tea placebo capsules Green tea placebo capsules Green tea placebo capsules Lycopene capsules Lycopene capsules Lycopene capsules
- Primary Outcome Measures
Name Time Method Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization 6 months
- Secondary Outcome Measures
Name Time Method Compliance (returned tablet counts and self-reported counts at 6 months) 6 months Attitudes and views of men and their spouses about dietary modification and participation in long-term study (qualitative interviews conducted throughout the study) 6 months Urinary symptoms as measured by the ICSmaleSF questionnaire (including voiding and incontinence scores, nocturia, frequency, and urinary-specific quality-of-life care data sources) 6 months PSA values at baseline and at 6 months 6 months Trial recruitment and randomization rates at each stage of the study 6 months Intervention tolerability (adverse event reporting during the six months of follow-up) 6 months Trial retention (participants completing 6-month follow-up and questionnaires) 6 months Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change) 6 months Weight and body mass index at 1 and 6 months 6 months Blood pressure at 1 and 6 months 6 months Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States 6 months
Trial Locations
- Locations (1)
Southmead Hospital
🇬🇧Bristol, England, United Kingdom