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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00413530 |
Primary Objective:
To compare the effects of daily consumption of pomegranate liquid extract, and placebo on end-of-treatment (52 weeks) prostate-specific antigen (PSA) doubling time in male subjects who have rising serum PSA levels after primary therapy for localized prostate cancer.
Secondary Objectives:
Condition | Intervention |
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Prostate Cancer |
Drug: Pomegranate Juice Other: Placebo Behavioral: Questionnaire |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Pomegranate Juice or Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pomegranate liquid extract
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Drug: Pomegranate Juice
Subjects will orally receive 8 ounces of pomegranate liquid extract (equivalent to 1.6 mmol of total polyphenols per day) or matching placebo daily.
Behavioral: Questionnaire
Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.
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2: Placebo Comparator
Matching placebo juice
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Other: Placebo
Subjects will orally receive 8 ounces of pomegranate liquid extract (equivalent to 1.6 mmol of total polyphenols per day) or matching placebo daily.
Behavioral: Questionnaire
Food-frequency questionnaires and quality of life questionnaires will be administered before and during the study.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Curtis A. Pettaway, MD | 713-792-3250 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Curtis A. Pettaway, MD |
Principal Investigator: | Curtis A. Pettaway, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Curtis A. Pettaway, MD,BS/Professor ) |
Study ID Numbers: | 2006-0220 |
Study First Received: | December 15, 2006 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00413530 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Pomegranate Juice Pomegranate Extract |
PomWonderful Questionnaire Placebo |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |