NCT00462813

An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]

Completed Phase 3 Last updated 6 August 2013

What this trial tests

Phase 3 trial testing oral microencapsulated diindolylmethane in Cervical Cancer in 3,000 participants. Completed in 1 January 2010.

Timeline

1 October 2004

Primary endpoint
1 June 2008

1 January 2010

Quick facts

Lead sponsor	Barts and the London School of Medicine and Dentistry
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Masking	double
Primary purpose	prevention
Enrollment	3,000
Start date	1 October 2004
Primary completion	1 June 2008
Estimated completion	1 January 2010
Sites	2 locations across United Kingdom

Drugs / interventions tested

• oral microencapsulated diindolylmethane — full drug profile →
• polymerase chain reaction
• cervical Papanicolaou test
• cytology specimen collection procedure
• colposcopic biopsy

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Precancerous Condition — all drugs for Precancerous Condition →

Sponsor

Barts and the London School of Medicine and Dentistry

Who can join

Eligibility, female only, with Cervical Cancer or Precancerous Condition. Patients with the condition only — healthy volunteers not accepted.

What's being measured

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

• Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months

Sponsor's own description

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical intraepithelial neoplasia or cervical cancer from forming.

PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it works compared to a placebo in treating patients with abnormal cervical cells.

Publications & conference data

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

1. Regulation of microRNAs by natural agents: new strategies in cancer therapies.
   Phuah NH, Nagoor NH. · · 2014 · cited 90× · PMID 25254214 · DOI 10.1155/2014/804510
2. 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
3. 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
4. HPV16 L1 and L2 DNA methylation predicts high-grade cervical intraepithelial neoplasia in women with mildly abnormal cervical cytology.
   Lorincz AT, Brentnall AR, Vasiljević N, Scibior-Bentkowska D, et al · · 2013 · cited 43× · PMID 23335178 · DOI 10.1002/ijc.28050
5. Effect of diindolylmethane supplementation on low-grade cervical cytological abnormalities: double-blind, randomised, controlled trial.
   Castañon A, Tristram A, Mesher D, Powell N, et al · · 2012 · cited 18× · PMID 22075942 · DOI 10.1038/bjc.2011.496
6. Investigating the Epigenetic Therapeutic Potential of Natural Compounds in Cancer.
   Zaczek A, Rodacka A. · · 2025 · PMID 41226811 · DOI 10.3390/ijms262110776