Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
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|ClinicalTrials.gov Identifier: NCT00982319|
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Broccoli sprout extract Drug: Mango juice||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: 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.
Drug: Broccoli sprout extract
100 µmols of sulforaphane (dissolvable)
Drug: Mango juice
150 mL of mango juice
Placebo Comparator: Mango juice
Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
Drug: Mango juice
150 mL of mango juice
- Absolute Change in Mean Proliferative Rate Measured by Ki67% [ Time Frame: Change from baseline to 14 days post-intervention ]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.
- Phase II Protein Expression Levels of Cytoprotective Enzymes Known to be Modulated by Sulforaphane as Well as Morphological Changes in DCIS Specimens [ Time Frame: Change from baseline to 14 days post-intervention ]Cytoprotective enzymes (NQ01 and AKR1C1 expression) based on immunohistochemical stains and qualitative assessment of morphological changes determined by study pathologists blinded to outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982319
|United States, Maryland|
|Johns Hopkins Medical Institution|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Kala Visvanathan, MD||Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center|