Broccoli Sprout Extract in Treating Patients With Breast Cancer

NCT ID: NCT01753908

Last Updated: 2019-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-21
• Study Completion Date: 2018-08-23

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.

Conditions

Ductal Breast Carcinoma; Ductal Breast Carcinoma In Situ; Estrogen Receptor Negative; Estrogen Receptor Positive; Invasive Breast Carcinoma; Lobular Breast Carcinoma; Postmenopausal; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Arm I (broccoli sprout extract)

Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.

Group Type: EXPERIMENTAL

Broccoli Sprout Extract

Intervention Type: DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Pharmacological Study

Intervention Type: OTHER

Urinary ITCs and metabolites measured

Arm II (placebo)

Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

Group Type: PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Pharmacological Study

Intervention Type: OTHER

Urinary ITCs and metabolites measured

Placebo

Intervention Type: OTHER

Given PO

Interventions

Broccoli Sprout Extract

Given PO

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Pharmacological Study

Urinary ITCs and metabolites measured

Intervention Type: OTHER

Placebo

Given PO

Intervention Type: OTHER

Other Intervention Names

placebo therapy; PLCB; sham therapy

Eligibility Criteria

Inclusion Criteria

• Postmenopausal (no menstrual cycle in the past 12 months)
• Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS)
• No neoadjuvant endocrine therapy or chemotherapy within 12 months
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Willing to avoid cruciferous vegetable intake during the study period (2 weeks)
• Demonstrate the ability to swallow and retain oral medication
• Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

• Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
• Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers
• Intolerance to broccoli/ITC-BSE taste
• Current ingestion of broccoli sprout extract, which may confound study results
• Current or recent treatment for any malignancy within the last one year, which may affect biomarkers
• History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
• Current diagnosis of Gastroesophageal Reflux Disease (GERD) with grade >3

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Young

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2012-01770

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 211911

Identifier Type: OTHER

Identifier Source: secondary_id

K07CA148888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 211911

Identifier Type: -

Identifier Source: org_study_id