Clinical trial · Interventional
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)
NCT00843167CI-TRIAL-00027244completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia. PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| broccoli sprout extract | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sulforaphane Supplement
- description
- Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
- interventionNames
- Dietary Supplement: broccoli sprout extract
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
- interventionNames
- Other: placebo
Primary outcomes (3)
- measure
- Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Diagnostic mammogram * English speaking EXCLUSION CRITERIA: * Pregnancy (as determined by urine human chorionic gonadotropin (hCG) test) * No biopsy referral after diagnostic mammogram * Patient reported breast feeding * Significant active medical illness which in the opinion of the investigator would preclude protocol treatment * History of or active liver disease or baseline total bilirubin greater than institutional upper limit of normal * Patient reported allergy or sensitivity to cruciferous vegetables * Use of oral antibiotics within three months prior to randomization * Oral steroid therapy at enrollment * Current therapy with valproate acid or SAHA * Current use of nutrient supplements or herbal remedies containing sulforaphane and unwillingness or inability to quit 72 hours prior to randomization and for the duration of the trial * Radiation for currently-diagnosed disease prior to or during study supplementation * Chemotherapy for currently-diagnosed disease prior to or during study supplementation
References
Publications (2)
- DERIVEDAtwell LL, Zhang Z, Mori M, Farris P, Vetto JT, Naik AM, Oh KY, Thuillier P, Ho E, Shannon J. Sulforaphane Bioavailability and Chemopreventive Activity in Women Scheduled for Breast Biopsy. Cancer Prev Res (Phila). 2015 Dec;8(12):1184-1191. doi: 10.1158/1940-6207.CAPR-15-0119. Epub 2015 Oct 28. PMID 26511489
- DERIVEDZhang Z, Atwell LL, Farris PE, Ho E, Shannon J. Associations between cruciferous vegetable intake and selected biomarkers among women scheduled for breast biopsies. Public Health Nutr. 2016 May;19(7):1288-95. doi: 10.1017/S136898001500244X. Epub 2015 Sep 2. PMID 26329135