Trial reportBreast cancer research and treatment2017
A randomized, placebo-controlled trial of diindolylmethane for breast cancer biomarker modulation in patients taking tamoxifen.
Trial report in Breast cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01391689 (Evaluation of Diindolylmethane Supplementation to Modulate Tamoxifen Efficacy in Breast Cancer The Diindolylmethane Efficacy Study), which is not on this map. Cited by 30 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of Diindolylmethane Supplementation to Modulate Tamoxifen Efficacy in Breast Cancer The Diindolylmethane Efficacy Study
Who cites it
30 citing papers in PubMed, 63 citations in OpenAlex.
- A randomized controlled trial of metformin in women with components of metabolic syndrome: intervention feasibility and effects on adiposity and breast density.Breast cancer research and treatment · 2021Trial
- 3,3-Diindolylmethane (DIM): a nutritional intervention and its impact on breast density in healthy BRCA carriers. A prospective clinical trial.Carcinogenesis · 2020Trial
- Reproducible automated breast density measure with no ionizing radiation using fat-water decomposition MRI.Journal of magnetic resonance imaging : JMRI · 2018Trial
- Novel 3,3'-diindolylmethane derivatives as multi-pathway modulators: targeting estrogen-dependent and independent breast cancer carcinogenesis.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Article
- Natural Compounds Targeting MAPK, PI3K/Akt, and JAK/STAT Signaling in Papillary Thyroid Cancer.International journal of molecular sciences · 2025Review
- Review
- Cruciferous Vegetables, Bioactive Metabolites, and Microbiome for Breast Cancer Prevention.Annual review of nutrition · 2025Review
- Unveiling the Multifaceted Pharmacological Actions of Indole-3-Carbinol and Diindolylmethane: A Comprehensive Review.Plants (Basel, Switzerland) · 2025Review
- 3,3'-Diindolylmethane improves pathology and neurological outcome following traumatic brain injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Article
- Exploring the impact of 3,3'-diindolylmethane on the urinary estrogen profile of premenopausal women.BMC complementary medicine and therapies · 2024Article
- Breast Cancer Screening and Prophylactic Mastectomy for High-Risk Women in Romania.Medicina (Kaunas, Lithuania) · 2024Review
- Nanoformulated 3'-diindolylmethane modulates apoptosis, migration, and angiogenesis in breast cancer cells.Heliyon · 2024Article
- Green and sustainable approaches for the Friedel-Crafts reaction between aldehydes and indoles.Beilstein journal of organic chemistry · 2024Review
- Karaya/Gellan-Gum-Based Bilayer Films Containing 3,3'-Diindolylmethane-Loaded Nanocapsules: A Promising Alternative to Melanoma Topical Treatment.Pharmaceutics · 2023Article
- Assessing breast density using the chemical-shift encoding-based proton density fat fraction in 3-T MRI.European radiology · 2023Article
- Synthetic Methodologies and Therapeutic Potential of Indole-3-Carbinol (I3C) and Its Derivatives.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Metabolic alteration of circulating steroid hormones in women with gestational diabetes mellitus and the related risk factors.Frontiers in endocrinology · 2023Article
- Indole-3-Carbinol Inhibits the Growth of Endometriotic Lesions by Suppression of Microvascular Network Formation.Nutrients · 2022Article
- Diindolylmethane Inhibits Cadmium-Induced Autophagic Cell Death via Regulation of Oxidative Stress in HEL299 Human Lung Fibroblasts.Molecules (Basel, Switzerland) · 2022Article
- Article
Corrections and comments
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Authors and funding
12 authors at 4 institutions in 1 country.
Funding
Abstract
purposeDiindolylmethane (DIM), a bioactive metabolite of indole-3-carbinol found in cruciferous vegetables, has proposed cancer chemoprevention activity in the breast. There is limited evidence of clinically relevant activity of DIM or long-term safety data of its regular use. A randomized, double-blind, placebo-controlled trial was conducted to determine the activity and safety of combined use of BioResponse DIM® (BR-DIM) with tamoxifen.
methodsWomen prescribed tamoxifen (n = 130) were randomly assigned oral BR-DIM at 150 mg twice daily or placebo, for 12 months. The primary study endpoint was change in urinary 2/16α-hydroxyestrone (2/16α-OHE1) ratio. Changes in 4-hydroxyestrone (4-OHE1), serum estrogens, sex hormone-binding globulin (SHBG), breast density, and tamoxifen metabolites were assessed.
resultsNinety-eight women (51 placebo, 47 DIM) completed intervention; compliance with treatment was >91%. BR-DIM increased the 2/16α-OHE1 ratio (+3.2 [0.8, 8.4]) compared to placebo (-0.7 [-1.7, 0.8], P < 0.001). Serum SHBG increased with BR-DIM compared to placebo (+25 ± 22 and +1.1 ± 19 nmol/L, respectively). No change in breast density measured by mammography or by MRI was observed. Plasma tamoxifen metabolites (endoxifen, 4-OH tamoxifen, and N-desmethyl-tamoxifen) were reduced in women receiving BR-DIM versus placebo (P < 0.001). Minimal adverse events were reported and did not differ by treatment arm.
conclusionIn patients taking tamoxifen for breast cancer, daily BR-DIM promoted favorable changes in estrogen metabolism and circulating levels of SHBG. Further research is warranted to determine whether BR-DIM associated decreases in tamoxifen metabolites, including effects on endoxifen levels, attenuates the clinical benefit of tamoxifen.
trial registrationClinicalTrials.gov NCT01391689.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.