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| Sponsor: | University of California, Los Angeles |
|---|---|
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00719030 |
Purpose
The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Dietary Supplement: Pomegranate pill Dietary Supplement: Pomegranate pill placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy |
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Pomegranate pill
|
Dietary Supplement: Pomegranate pill
Pomegranate extract pill
Other Name: PomX
|
| Placebo Comparator: 2 |
Dietary Supplement: Pomegranate pill placebo
Pomegranate pill placebo
Other Name: POM-X placebo
|
Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Allan Pantuck, M.D. | 310-206-2436 | apantuck@mednet.ucla.edu |
| Contact: Nazy Zomorodian, N.P. | 310-794-3550 | nzomorodian@mednet.ucla.edu |
| United States, California | |
| UCLA | Active, not recruiting |
| Los Angeles, California, United States, 90095 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Michael Carducci, MD 410-614-3977 carducci@jhmi.edu | |
| Contact: Serina King, CCRP (410)-614-6139 sking18@jhmi.edu | |
| Principal Investigator: Michael Carducci, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Stephen J Freedland, MD 919-668-8361 steve.freedland@duke.edu | |
| Contact: Trish Creel, RN, BSN,OCN,CCRP 919-668-0635 patricia.creel@duke.edu | |
| Principal Investigator: Stephen J Freedland, MD | |
| Principal Investigator: | Allan J Pantuck, MD | University of California, Los Angeles |
| Principal Investigator: | Michael Carducci, MD | Johns Hopkins Medical Center |
| Principal Investigator: | Stephen J Freedland, MD | Duke University |
More Information
| Responsible Party: | Allan Pantuck, M.D., UCLA |
| ClinicalTrials.gov Identifier: | NCT00719030 History of Changes |
| Other Study ID Numbers: | GUP-0515-02 |
| Study First Received: | July 15, 2008 |
| Last Updated: | May 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |