Phase 2 N=54 Randomized Triple-blind Treatment

Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy

Breast Cancer · Precancerous Condition

Bottom Line

View on ClinicalTrials.gov: NCT00843167 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy — 1.00; -0.05 µM/mM creatinine

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: broccoli sprout extract (Dietary_supplement); placebo (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: OHSU Knight Cancer Institute
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy	1.00; -0.05	—
PRIMARY Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy	-1.39; 0.42; 0.98; 0.23; -0.48; 0.28	—
PRIMARY Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy	-80.39; 27.52	—
SECONDARY Treatment Compliance	19; 16	—

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00843167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.