Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | April 2009 |
| End Date: | November 2013 |
Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk
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.
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.
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.
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.
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
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