Indole-3-Carbinol in Preventing Cancer in Healthy Participants

NCT00100958 | Completed Phase 1

• 2 other identifiers: CDR0000406002KUMC-HSC-9139-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

indole-3-carbinol DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Kansas: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

MeSH Terms

Interventions

indole-3-carbinol

Study Officials

• Gregory Reed, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: November 1, 2004
• Last Updated: July 24, 2008

Record last verified: 2006-05

Locations

US (1)