Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
NCT00042731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2012-09-24
Summary
RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Lycopene
Daily administration as outlined in treatment arm(s)
- DIETARY_SUPPLEMENT
-
Multivitamin
Daily administration as outlined in treatment arm(s)
- DIETARY_SUPPLEMENT
-
Soy isoflavones
Daily administration as outlined in treatment arm(s)
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Nagi B. Kumar, PhD, RD, FADA · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-07-31
- Primary Completion
- 2006-08-31
- Completion
- 2006-08-31
Countries
- United States
Study Locations
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