Trial record 3 of 41 for:
pomegranate
A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of California, Los Angeles.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, Los Angeles
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00719030
First received: July 15, 2008
Last updated: May 24, 2010
Last verified: October 2009
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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 |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Pomegranate oxidative stress [ Time Frame: On day of prostate surgery following 4 weeks of taking POM-X or placebo. ] [ Designated as safety issue: No ]
| 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
|
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.
- Radical prostatectomy scheduled at Duke or Johns Hopkins.
- Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.
- Age ≥ 18 years of age.
- Willingness and ability to sign an informed consent document.
- Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
- No prior allergy to pomegranate dietary agents.
- No significant medical or psychiatric condition that would make the patient a poor protocol candidate.
- The patient agrees to stop taking dietary or vitamin supplements (lycopene, vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto) for 2-weeks prior to staring the study.
- The patient is not taking LHRH agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy.
- Patient has not received experimental medications within the past six months.
Exclusion Criteria:
- Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate.
- Concomitant or antecedent hormonal therapy.
- Known allergy to pomegranate juice.
- Subjects unable or unwilling to comply with protocol requirements.
- Evidence of metastatic disease on physical examination or on CT or bone scan.
- Use of finasteride, dutasteride at any point during the study.
- Clinically significant abnormal laboratory value >2X the upper limit of normal (2XULN).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719030
Contacts
| Contact: Allan Pantuck, M.D. | 310-206-2436 | apantuck@mednet.ucla.edu |
| Contact: Nazy Zomorodian, N.P. | 310-794-3550 | nzomorodian@mednet.ucla.edu |
Locations
| 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 | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| 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
No publications provided
| 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 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013