Clinical trial · Interventional
Indole-3-Carbinol in Preventing Cancer in Healthy Participants
Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product
NCT00100958CI-TRIAL-00001617completedPhase 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 is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer. PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indole-3-carbinol | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Healthy participants * Non-smoker * No drug abuse, as determined by urine cotinine and baseline drug screen PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * Not specified Life expectancy * At least 12 months Hematopoietic * Absolute granulocyte count \> 1,500/mm\^3 * Hemoglobin \> 10 g/dL Hepatic * Bilirubin \< 1.8 mg/dL * AST and ALT \< 110 U/L * Alkaline phosphatase \< 300 U/L Renal * Creatinine \< 2.0 mg/dL * Albumin \> 3.0 g/dL Pulmonary * No asthma Other * Not pregnant or nursing * Negative pregnancy test * Weight within 20% of ideal body weight by the Metropolitan Life table * No serious drug allergies * No arthritis * No acute, unstable, chronic, or recurring medical condition * No strict vegetarians * No diabetes * No evidence of an active malignancy * No other serious intolerance or allergies * Mild seasonal allergies allowed * No other serious acute or chronic illness * None of the following chronic conditions: * Headaches * Dysphoria * Fatigue * Dizziness * Blurred vision * Insomnia * Rhinorrhea * Nausea * Vomiting * Abdominal pain * Diarrhea * Constipation * Premenstrual syndrome * Cessation of menses within the past 10 days (menstruating women only) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Concurrent oral contraceptives allowed Radiotherapy * Not specified Surgery * Not specified Other * More than 21 days since prior medications, herbal products, dietary supplements, or high-dose vitamins * More than 3 months since prior investigational drugs * At least 14 days since prior and no concurrent ingestion of cruciferous vegetables, including any of the following: * Broccoli * Cabbage, including coleslaw * Cauliflower * Bok-choy * Brussels sprouts * Collards * Kale * Kohlrabi * Mustard greens * Rutabaga * Turnip * Watercress * At least 7 days since prior and no concurrent alcohol consumption * At least 48 hours since prior ingestion of grapefruit-containing foods and beverages * No concurrent chronic drug therapy * No other concurrent supplements, including dietary supplements, vitamins, herbal products, or over-the-counter medications
References
Publications (0)
Data not yet available
No reference posted for this study.