Prostate Cancer Clinical Trial
Official title:
The Effect of Lycopene on DNA Damage in Human Prostate
Verified date | October 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Prostate cancer - Benign prostate hyperplasia - High blood levels of prostate-specific antigen - Enlarged prostate PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - Not specified |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability of prostatic tissue to accumulate doses of lycopene | No | ||
Primary | Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing | No | ||
Primary | Effect of lycopene on lipid peroxidation marker malondialdehyde in serum | No | ||
Primary | Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention | No | ||
Primary | Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate | No | ||
Primary | Prostate and blood uptake of the chemoprevention agent lycopene | No |
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