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

NCT00982319 | Completed Phase 2 Results DMC

• 1 other identifier: J0822
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Broccoli Sprout Extract; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Mean Proliferative Rate Measured by Ki67%

  Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.

  Change from baseline to 14 days post-intervention

Secondary Outcomes (1)

• Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor

  Change from baseline to 14 days post-intervention

Study Arms (2)

Broccoli sprout extract

EXPERIMENTAL

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.

Drug: Broccoli sprout extract; Drug: Mango juice

Mango juice

PLACEBO COMPARATOR

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

Drug: Mango juice

Interventions

Broccoli sprout extract DRUG

100 µmols of sulforaphane (dissolvable)

Broccoli sprout extract

Mango juice DRUG

150 mL of mango juice

Broccoli sprout extract; Mango juice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Johns Hopkins Medical Institution

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Eligible patients had to have their definitive breast cancer surgery at Johns Hopkins Hospital

Results Point of Contact

• Title: Dr. Kala Visvanathan
• Organization: Sidney Kimmel Comprehensive Cancer Center

kvisvan1@jhu.edu

410-614-1112

Study Officials

• Kala Visvanathan, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 21, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-11

Locations

US (1)