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Indole-3-Carbinol in Preventing Cancer in Healthy Participants

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: January 7, 2005
Last updated: July 23, 2008
Last verified: May 2006

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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: indole-3-carbinol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2004
Detailed Description:



  • Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
  • Determine the safety and tolerability of this drug in these participants.
  • Determine the pharmacokinetics of this drug in these participants.


  • Determine the effects of this drug on selected markers of sexual function in these participants.
  • Determine the effects of this drug on markers of susceptibility to cancer in these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.

  • Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
  • Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD.

Participants are followed on days 2, 3, and 6.

PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • Healthy participants

    • Non-smoker
    • No drug abuse, as determined by urine cotinine and baseline drug screen



  • 18 to 70

Performance status

  • Not specified

Life expectancy

  • At least 12 months


  • Absolute granulocyte count > 1,500/mm^3
  • Hemoglobin > 10 g/dL


  • Bilirubin < 1.8 mg/dL
  • AST and ALT < 110 U/L
  • Alkaline phosphatase < 300 U/L


  • Creatinine < 2.0 mg/dL
  • Albumin > 3.0 g/dL


  • No asthma


  • 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)


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Concurrent oral contraceptives allowed


  • Not specified


  • Not specified


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00100958

United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Sponsors and Collaborators
University of Kansas
National Cancer Institute (NCI)
Principal Investigator: Gregory Reed, PhD University of Kansas
  More Information Identifier: NCT00100958     History of Changes
Other Study ID Numbers: CDR0000406002
Study First Received: January 7, 2005
Last Updated: July 23, 2008

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents processed this record on August 17, 2017