Clinical trial · Interventional
Lycopene In Preventing of Prostate Cancer
Single Dose Pharmacokinetic Study of Lycopene Delivered in a Well Defined Food-Based Lycopene Delivery System (Tomato Paste-oil Mixture) in Healthy Male Volunteers Between 18 and 45 Years of Age
NCT00006078CI-TRIAL-00011057completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer. PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lycopene | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions * Baseline serum lycopene less than 600 nM PATIENT CHARACTERISTICS: Age: * 18 to 45 Performance status: * Karnofsky 100% Life expectancy: * Not specified Hematopoietic: * Hematologic function normal Hepatic: * Liver function normal * No hepatic disease Renal: * Kidney function normal * No renal disease Cardiovascular: * No hypertension requiring medication * No cardiovascular disease * Normal EKG Other: * No evidence of a psychiatric disorder * Must be within 15% of ideal body weight based on standard weight tables * No history of smoking within the past 3 months * At least 72 hours since prior alcohol consumption and no history of alcohol abuse * No history of gastrointestinal malabsorption or any other condition that could affect drug absorption * No allergy to tomato based products * No active malignancy at any site * No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 14 days since prior prescription drugs * No concurrent regular prescription medications * At least 30 days since other prior experimental drugs * No concurrent participation in any other experimental trial
References
Publications (0)
Data not yet available
No reference posted for this study.