NCT01022333

The Potential for Oral DIM Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers

Status unknown Phase 1 Last updated 30 November 2009

What this trial tests

Phase 1 trial testing Diindolylmethane (DIM) in Breast Cancer in 300 participants. Status unknown.

Timeline

1 July 2009

Primary endpoint
1 July 2010

1 December 2010

Quick facts

Lead sponsor	Women's College Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	300
Start date	1 July 2009
Primary completion	1 July 2010
Estimated completion	1 December 2010
Sites	1 location across Canada

Drugs / interventions tested

• Diindolylmethane (DIM)

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Women's College Hospital

Who can join

Adults 25 to 45, female only, with Breast Cancer. Healthy volunteers can join.

What's being measured

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

• Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation
  Time frame: 6 months

Sponsor's own description

Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer nutrients have been proposed, however, it is important that diet supplements be evaluated prior to general recommendation.

The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential interest. One dietary supplement that is thought to have potential for BRCA1 carriers is diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables. DIM - is found in vegetables like broccoli and is available as a supplement in health food stores. The investigators think that DIM may increase the production of the normal copy of BRCA1 and offset the effect of the mutation.

The purpose of this study is to determine that there is a potential for oral DIM supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation carriers. The results of the study will also serve as an evaluation of the current use and success of preventive strategies for BRCA1 mutation carriers.

Publications & conference data

4 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. 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
3. Natural compounds as anticancer agents: Experimental evidence.
   Wang J, Jiang YF. · · 2012 · cited 56× · PMID 24520533 · DOI 10.5493/wjem.v2.i3.45
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