Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
This study is ongoing, but not recruiting participants.
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00843167
First received: February 12, 2009
Last updated: April 11, 2013
Last verified: February 2013
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Purpose
RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia.
PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Precancerous Condition |
Dietary Supplement: broccoli sprout extract Other: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sulforaphane: A Dietary HDAC Inhibitor in DCIS |
Resource links provided by NLM:
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Change in isothiocyanate in urine and blood samples as assessed at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Change in Ki-67 and apoptosis as assessed at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Change in H3 and H4 as assessed by IHC at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Change in HDAC activity as assessed at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Regular intervals ] [ Designated as safety issue: Yes ]
- Treatment compliance [ Time Frame: Regular intervals ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Dietary Supplement: broccoli sprout extract
Given orally
|
|
Placebo Comparator: Arm II
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Other: placebo
Given orally
|
Detailed Description:
OBJECTIVES:
- To determine the correlation between supplemental sulforaphane (broccoli sprout extract) dose and concentrations of sulforaphane and its metabolites in blood and urine samples from women positive for cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
- To determine the effect of this supplement on biomarkers of prognosis in these patients.
- To determine the effect of this supplement on HDAC inhibition in peripheral blood cell and normal and cancerous breast tissue samples from these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
Blood and urine samples are collected at baseline and after completion of study treatment for laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or lumpectomy) also undergo breast tissue sample collection at baseline and at the time of surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and apoptosis (TUNEL assay).
Patients complete questionnaires at baseline and periodically during study about their dietary history, family history, cruciferous vegetable intake, adverse events, and dietary and medication changes.
After completion of study therapy, patients are followed at/around 30 days.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
- Diagnostic mammogram
- English speaking
EXCLUSION CRITERIA:
- Pregnancy (as determined by urine hCG test)
- No biopsy referral after diagnostic mammogram
- Patient reported breast feeding
- Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
- History of or active liver disease or baseline total bilirubin greater than institutional upper limit of normal
- Patient reported allergy or sensitivity to cruciferous vegetables
- Use of oral antibiotics within three months prior to randomization
- Oral steroid therapy at enrollment
- Current therapy with valproate acid or SAHA
- Current use of nutrient supplements or herbal remedies containing sulforaphane and unwillingness or inability to quit 72 hours prior to randomization and for the duration of the trial
- Radiation for currently-diagnosed disease prior to or during study supplementation
- Chemotherapy for currently-diagnosed disease prior to or during study supplementation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843167
Locations
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Jackilen Shannon, PhD | OHSU Knight Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00843167 History of Changes |
| Other Study ID Numbers: | CDR0000634111, R21CA132236, P30CA069533, OHSU-4702 |
| Study First Received: | February 12, 2009 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by OHSU Knight Cancer Institute:
|
mammography biopsy ductal breast carcinoma in situ atypical ductal breast hyperplasia |
Additional relevant MeSH terms:
|
Breast Neoplasms Precancerous Conditions Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013