NCT00784394

Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-indolylmethane (DIM)

Completed Phase 1 Last updated 28 December 2016

What this trial tests

Phase 1 trial testing diindolylmethane in Healthy, no Evidence of Disease in 20 participants. Completed in 1 October 2009.

Timeline

1 April 2004

Primary endpoint
1 October 2009

1 October 2009

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	20
Start date	1 April 2004
Primary completion	1 October 2009
Estimated completion	1 October 2009
Sites	1 location across United States

Drugs / interventions tested

• diindolylmethane — full drug profile →
• placebo
• pharmacological study — full drug profile →
• laboratory biomarker analysis — full drug profile →
• quality-of-life assessment

Conditions studied

• Healthy, no Evidence of Disease — all drugs for Healthy, no Evidence of Disease →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 70, any sex, with Healthy, no Evidence of Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Attenuation of multi-targeted proliferation-linked signaling by 3,3'-diindolylmethane (DIM): from bench to clinic.
   Banerjee S, Kong D, Wang Z, Bao B, et al · · 2011 · cited 90× · PMID 21703360 · DOI 10.1016/j.mrrev.2011.06.001
2. Harnessing the fruits of nature for the development of multi-targeted cancer therapeutics.
   Sarkar FH, Li Y. · · 2009 · cited 88× · PMID 19660870 · DOI 10.1016/j.ctrv.2009.07.001
3. Chemopreventive properties of 3,3'-diindolylmethane in breast cancer: evidence from experimental and human studies.
   Thomson CA, Ho E, Strom MB. · · 2016 · cited 72× · PMID 27261275 · DOI 10.1093/nutrit/nuw010
4. DNA-Methyltransferase 1 Induces Dedifferentiation of Pancreatic Cancer Cells through Silencing of Krüppel-Like Factor 4 Expression.
   Xie VK, Li Z, Yan Y, Jia Z, et al · · 2017 · cited 43× · PMID 28659310 · DOI 10.1158/1078-0432.ccr-17-0387
5. Phytochemicals and PI3K Inhibitors in Cancer-An Insight.
   Suvarna V, Murahari M, Khan T, Chaubey P, et al · · 2017 · cited 34× · PMID 29311925 · DOI 10.3389/fphar.2017.00916