Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue

NCT ID: NCT00982319

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-11-30

Brief Summary

The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.

Detailed Description

A double-blind randomized Phase II chemoprevention trial of BSE versus placebo will be conducted in up to 35 women diagnosed with DCIS on core biopsy prior to their definitive surgery (study diagram below). The primary study endpoint will be a decrease in the mean proliferative rate measured by Ki67%.

Women diagnosed with DCIS on core or incisional/excisional biopsy scheduled for definitive surgery at Johns Hopkins Hospital will be recruited for this study. Participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). Additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. On the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Broccoli sprout extract

Patients will be randomized to 14 day intervention of broccoli sprout extract and mango juice consisting of a dose of 100 µmols of sulforaphane dissolved in 150 mL mango juice once a day.

Group Type: EXPERIMENTAL

Broccoli sprout extract

Intervention Type: DRUG

100 µmols of sulforaphane (dissolvable)

Mango juice

Intervention Type: DRUG

150 mL of mango juice

Mango juice

Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.

Group Type: PLACEBO_COMPARATOR

Mango juice

Intervention Type: DRUG

150 mL of mango juice

Interventions

Broccoli sprout extract

100 µmols of sulforaphane (dissolvable)

Intervention Type: DRUG

Mango juice

150 mL of mango juice

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female 18 + years of age
• Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery
• Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening
• Agree to avoid cruciferous vegetable/condiment intake for 14 days
• Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes

Exclusion Criteria

• Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ
• Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening
• Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)
• Smoked within the past 12 months prior to eligibility screening;
• Active infection or inflammation of the breast at time of eligibility screening
• Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kala Visvanathan, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center

Locations

Johns Hopkins Medical Institution

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

J0822

Identifier Type: -

Identifier Source: org_study_id