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Diindolylmethane in Preventing Cancer in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784394
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : December 29, 2016
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase I clinical trial studies the side effects and best dose of diindolylmethane in preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people who eat a chemical that is normally found in vegetables, including cabbage, broccoli, Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development of cancer.

Condition or disease Intervention/treatment Phase
Healthy, no Evidence of Disease Drug: diindolylmethane Other: placebo Other: pharmacological study Other: laboratory biomarker analysis Other: quality-of-life assessment Phase 1

Detailed Description:


I. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are safe and well- tolerated.

II. To determine the pharmacokinetics of these single oral doses of DIM.

OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment arms.

ARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1.

ARM II: Participants receive a single dose of placebo orally (PO) on day 1.

After completion of study treatment, participants are followed up on days 2, 3, and 6.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)
Study Start Date : April 2004
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: Arm I (diindolylmethane)
Participants receive a single dose of diindolylmethane PO on day 1.
Drug: diindolylmethane
Given PO
Other Name: DIM

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Placebo Comparator: Arm II (placebo)
Participants receive a single dose of placebo orally (PO) on day 1.
Other: placebo
Given PO
Other Name: PLCB

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD), defined as the highest dose at which no grade 2 or higher toxicities are seen [ Time Frame: Up to day 6 ]
    Frequencies and percents will be used to summarize the toxicities seen at each dose level and overall. Descriptive statistics will be calculated on all variables of interest: frequencies and percentages will be used to summarize categorical variables and medians, and ranges will summarize quantitative variables.

Secondary Outcome Measures :
  1. Pharmacokinetics of diindolylmethane [ Time Frame: Baseline and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration ]
    Pharmacokinetic parameters such as half-life, maximum concentration (Cmax), time of Cmax (Tmax), and area under the concentration-time curve (AUC) will be calculated for all subjects who complete the study. It is anticipated that a one-compartment elimination model will fit the data. These parameters will be summarized at each dose and overall with median and ranges.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Non-smokers and non-users of abuse drugs as confirmed by urine cotinine (Accutest NicoMeter Urine Professional strip or equivalent test) and drug screen at visit 1
  • Free of acute, unstable, chronic or recurring medical conditions based on history, physical examination, laboratory tests; the laboratory tests to be performed will be: blood serum chemistry screen to include comprehensive metabolic panel (glucose, creatinine, urea nitrogen [blood urea nitrogen (BUN)], sodium, potassium, chloride, calcium, total bilirubin, protein, albumin, globulin, cholesterol and the enzymes alkaline phosphatase, aspartate aminotransferase [AST], and alanine aminotransferase [ALT]) and lipid panel (total, low density lipoprotein [LDL] and high density lipoprotein [HDL] cholesterol and triglycerides); complete blood count including differential and platelet count; prothrombin time; and routine urinalysis; values for laboratory tests must be within the ranges below grade 2 of Common Toxicity Criteria (CTC) and/or as specified below:
  • Hemoglobin > 10 g/dL
  • Absolute granulocyte count > 1500/ìL
  • Creatinine < 2.0 mg/dl
  • Albumin > 3.0 g/dl
  • Bilirubin < 1.8 mg/dl
  • AST < 110 U/l
  • ALT < 110 U/l
  • Alkaline phosphatase < 300 U/l
  • Subjects must weigh +/- 20% of ideal body weight by the Metropolitan Life tables
  • Men or women who are strict vegetarians or who eat more than 3 medium servings (1/2 cup each) of cruciferous vegetables per week will be excluded; those who stop ingesting cruciferous vegetables >= 14 days and alcohol >= 7 days before starting DIM and agree to refrain from taking them for the duration of the study will not be excluded; cruciferous vegetables include broccoli, cabbage (including coleslaw), cauliflower, bok-choy, Brussels sprouts, collards, kale, kohlrabi, mustard greens, rutabaga, turnip, and watercress; participants will be asked to complete a brief diet questionnaire listing these vegetables to assess these criteria; caffeine- and grapefruit-containing foods and beverages are to be avoided for at least 48 hours before visit 2 (DIM dosing)

Exclusion Criteria:

  • Subjects with serious drug allergies or other serious intolerance or allergies will be excluded; those with mild seasonal allergies will be accepted
  • Subjects with chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia, rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar conditions
  • Subjects with a serious acute or chronic illness (diabetes, arthritis, asthma, etc.) or requiring chronic drug therapy, who continuously take supplements or have taken an investigational drug within the past three months
  • Subjects who have evidence of an active malignancy or have received chemotherapy, and/or antiestrogen therapy
  • Subjects who have a life expectancy of < 12 months
  • Subjects who have regularly taken over the past 21 days any concomitant medications, herbal products, dietary supplements or vitamins; women taking oral contraceptives will be accepted; women who are pregnant (positive urine human chorionic gonadotropin [hCG] at visit 2) or lactating will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784394

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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Aryeh Hurwitz University of Kansas Medical Center

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00784394     History of Changes
Other Study ID Numbers: NCI-2014-00523
NCI-2014-00523 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
KUMC-HSC-9139 ( Other Identifier: University of Kansas Medical Center )
N01-CN-35008-1 ( Other Identifier: DCP )
N01CN35008 ( Other Identifier: US NIH Grant/Contract Award Number )
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents