Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-17 @ 5:00 AM
Study NCT ID:
NCT01753908
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Broccoli Sprout Extract in Treating Patients With Breast Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.
II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).
III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.
IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.
SECONDARY OBJECTIVES:
I. To determine tolerability of ITC-BSE and compliance in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.
ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
After completion of study treatment, patients are followed up at 30 days.
I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.
II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).
III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.
IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.
SECONDARY OBJECTIVES:
I. To determine tolerability of ITC-BSE and compliance in breast cancer patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.
ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
After completion of study treatment, patients are followed up at 30 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01770 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 211911 | OTHER | Roswell Park Cancer Institute | View | |
| K07CA148888 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA016056 | NIH | None | https://reporter.nih.gov/quic… | View |