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Lycopene or Green Tea in Treating Patients With Prostate Cancer Previously Enrolled on RADCLIFFE-PROTECT and Currently Enrolled on CRUK-ProMPT

2014-08-27 03:14:32 | BioPortfolio

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 on RADCLIFFE-PROTECT and currently enrolled on CRUK-ProMPT.

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 RADCLIFFE-PROTECT and currently enrolled on CRUK-ProMPT treated with lycopene versus green tea.

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: This is a multicenter study. Patients are stratified according to PSA test levels obtained from RADCLIFFE-PROTECT study recruitment clinic (< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2 treatment arms.

- Arm I (lycopene): Patients receive 1 of the following treatment regimes.

- Regimen 1: Patients receive dietary advice regarding a daily portion of cooked tomatoes rich in lycopene. Patients also receive oral placebo capsules once daily.

- Regimen 2: Patients also receive dietary advice recommending 5 daily portions of fruit and vegetables. Patients also receive tomato-derived lycopene supplement capsules once daily. .

- Regimen 3: Patients receive healthy dietary advice. Patients also receive oral placebo capsules once daily.

- Arm II (green tea): Patients receive 1 of the following treatment regimes.

- Regimen 1: Patients receive oral green tea capsules once daily.

- Regimen 2: Patients receive oral placebo capsules once daily.

- Regimen 3: Patients receive dietary advice regarding drinking green tea. Patients complete quality-of-life questionnaires on urinary symptoms (ICSmaleSF questionnaire/FTQ1), general health status [Hospital Anxiety and Depression scale (HAD) and Profile of Moods States], and current diet (Food Frequency Questionnaire/FTQ1a) periodically.

Patients are followed at 1 and 6 months after randomization.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

compliance monitoring, green tea extract, lycopene, questionnaire administration, quality-of-life assessment

Location

University of Bristol
Bristol
England
United Kingdom
BS8 2PR

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:32-0400

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