NCT00212381

Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)

Completed Phase 3 Last updated 27 March 2017

What this trial tests

Phase 3 trial testing di indolylmethane (DIM) in Cervical Dysplasia in 62 participants. Completed in 1 July 2010.

Timeline

1 September 2000

Primary endpoint
1 January 2006

1 July 2010

Quick facts

Lead sponsor	New York Presbyterian Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	62
Start date	1 September 2000
Primary completion	1 January 2006
Estimated completion	1 July 2010
Sites	1 location across United States

Drugs / interventions tested

• di indolylmethane (DIM) — full drug profile →
• Red rice bran

Conditions studied

• Cervical Dysplasia — all drugs for Cervical Dysplasia →

Sponsor

New York Presbyterian Hospital

Who can join

Adults 18 to 80, female only, with Cervical Dysplasia. Healthy volunteers can join.

What's being measured

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

• Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
  Time frame: 3 months
  To determine if oral DIM is effective in promoting the regression of CIN in women

Sponsor's own description

To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.

Publications & conference data

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

1. Redox-directed cancer therapeutics: molecular mechanisms and opportunities.
   Wondrak GT. · · 2009 · cited 324× · PMID 19496700 · DOI 10.1089/ars.2009.2541
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. 3,3'-Diindolylmethane and indole-3-carbinol: potential therapeutic molecules for cancer chemoprevention and treatment via regulating cellular signaling pathways.
   Reyes-Hernández OD, Figueroa-González G, Quintas-Granados LI, Gutiérrez-Ruíz SC, et al · · 2023 · cited 32× · PMID 37633886 · DOI 10.1186/s12935-023-03031-4