CompletedPhase 2

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

United States54 participantsStarted 2009-08

Plain-language 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.

Who can participate

Age range

21 Years – 120 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy

Timeframe: Baseline and end of study (up to 8 weeks)

Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy

Timeframe: Baseline and end of study (up to 8 weeks)

Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy

Timeframe: Baseline and End of Study (up to 8 weeks)

Trial details

NCT IDNCT00843167

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2014-12-30

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

21 Years – 120 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy

Timeframe: Baseline and end of study (up to 8 weeks)

Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy

Timeframe: Baseline and end of study (up to 8 weeks)

Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy

Timeframe: Baseline and End of Study (up to 8 weeks)