NCT01391689

Evaluation of Diindolylmethane Supplementation to Modulate Tamoxifen Efficacy in Breast Cancer The Diindolylmethane Efficacy Study

Completed NA Last updated 31 October 2017

What this trial tests

NA trial testing diindolylmethane in Stage IA Breast Cancer in 144 participants. Completed in 31 July 2016.

Timeline

1 February 2011

Primary endpoint
1 September 2014

31 July 2016

Quick facts

Lead sponsor	University of Arizona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	144
Start date	1 February 2011
Primary completion	1 September 2014
Estimated completion	31 July 2016
Sites	1 location across United States

Drugs / interventions tested

• diindolylmethane — full drug profile →
• placebo

Conditions studied

• Stage IA Breast Cancer — all drugs for Stage IA Breast Cancer →
• Stage IB Breast Cancer — all drugs for Stage IB Breast Cancer →
• Stage II Breast Cancer — all drugs for Stage II Breast Cancer →
• Stage IIIA Breast Cancer — all drugs for Stage IIIA Breast Cancer →

Sponsor

University of Arizona

Who can join

19 and older, female only, with Stage IA Breast Cancer or Stage IB Breast Cancer. 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.

• Urinary 2OHE1:16alpha OHE1 ratio
  Time frame: Up to 18 months
  estrogen metabolites measured in ng/100ul; this outcome will also be reported as a ratio

Sponsor's own description

This phase II/III trial studies how well diindolylmethane (DIM) works and compares it to placebo in treating patients with breast cancer. DIM may slow the growth of tumor cells and be an effective treatment for breast cancer.

Publications & conference data

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

1. Therapeutic modulators of STAT signalling for human diseases.
   Miklossy G, Hilliard TS, Turkson J. · · 2013 · cited 343× · PMID 23903221 · DOI 10.1038/nrd4088
2. 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
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. Natural compounds as anticancer agents: Experimental evidence.
   Wang J, Jiang YF. · · 2012 · cited 56× · PMID 24520533 · DOI 10.5493/wjem.v2.i3.45
5. 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
6. A randomized, placebo-controlled trial of diindolylmethane for breast cancer biomarker modulation in patients taking tamoxifen.
   Thomson CA, Chow HHS, Wertheim BC, Roe DJ, et al · · 2017 · cited 43× · PMID 28560655 · DOI 10.1007/s10549-017-4292-7
7. Reproducible automated breast density measure with no ionizing radiation using fat-water decomposition MRI.
   Ding J, Stopeck AT, Gao Y, Marron MT, et al · · 2018 · cited 21× · PMID 29630755 · DOI 10.1002/jmri.26041
8. Medicinal Plants for Overcoming Drug Resistance in Cervical Cancer.
   Marema TP, Laka K, Mbita Z. · · 2026 · PMID 41594926 · DOI 10.3390/biology15020191