Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416390
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2006-12-27
Brief Title:
Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Effect of Lycopene on DNA Damage in Human Prostate
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention is the use of certain substances to keep cancer from forming growing or coming back Eating a diet high in lycopene a substance found in tomatoes and tomato products may keep cancer from forming or growing Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer
PURPOSE This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia
PURPOSE This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia
Detailed Description:
OBJECTIVES
Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia
Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing
Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum
Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
Measure prostate and blood uptake of the chemoprevention agent lycopene
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral lycopene once daily for 3 weeks
Arm II Patients receive oral placebo once daily for 3 weeks In both arms patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy
Blood samples are collected at baseline and before surgery for biomarkerlaboratory studies
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia
Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing
Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum
Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
Measure prostate and blood uptake of the chemoprevention agent lycopene
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral lycopene once daily for 3 weeks
Arm II Patients receive oral placebo once daily for 3 weeks In both arms patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy
Blood samples are collected at baseline and before surgery for biomarkerlaboratory studies
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UIC-1999-0489 | None | None | None |