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

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Mango juice; Drug: Broccoli sprout extract

Study type: Interventional

Funder types: Other

Identifiers

NCT00982319

J0822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Broccoli sprout extract

Experimental group

Description:

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.

Treatment:

Drug: Broccoli sprout extract

Drug: Mango juice

Mango juice

Placebo Comparator group

Description:

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

Treatment:

Drug: Mango juice