NCT01105338CompletedPhase 2
Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Bristol
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 69 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.0 ng/mL with a negative biopsy No major comorbidities No other cancers or prior prostate malignancy No history of allergic reactions to green tea or lycopene-containing products, including guava or watermelon
Exclusion Criteria
- •No concurrent finasteride or dutasteride
Arms & Interventions
Green tea drink
Active Comparator
Green tea drink
Intervention: Green tea drink (Behavioral)
Green tea capsules
Active Comparator
Green tea capsules
Intervention: green tea capsules (Dietary Supplement)
Green tea placebo capsules
Placebo Comparator
Green tea placebo capsules
Intervention: Green tea placebo capsules (Other)
Lycopene capsules
Active Comparator
Lycopene capsules
Intervention: Lycopene capsules (Dietary Supplement)
Lycopene placebo capsules
Placebo Comparator
Lycopene placebo capsules
Intervention: Lycopene placebo capsules (Other)
Tomato rich diet
Active Comparator
Tomato rich diet
Intervention: Tomato rich diet (Other)
Outcomes
Primary Outcomes
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
Time Frame: 6 months
Secondary Outcomes
- 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)
Investigators
Dr Athene Lane
Study Coordinator and Senior Research Fellow
University of Bristol
Study Sites (1)
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