Broccoli Sprout Extract in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia - Full Text View

Sponsor:	OHSU Knight Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00843167

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 newly diagnosed ductal carcinoma in situ and/or atypical ductal hyperplasia.

Condition	Intervention	Phase
Breast Cancer Precancerous Condition	Dietary Supplement: broccoli sprout extract Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Sulforaphane: A Dietary HDAC Inhibitor in DCIS

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Change in isothiocyanate in urine, blood, and nipple aspirate fluid samples as assessed at baseline and after completion of study therapy [ Designated as safety issue: No ]
Change in Ki-67 and apoptosis as assessed at baseline and after completion of study therapy [ Designated as safety issue: No ]
Change in H3 and H4 as assessed by IHC at baseline and after completion of study therapy [ Designated as safety issue: No ]
Change in HDAC activity as assessed at baseline and after completion of study therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Treatment compliance [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	August 2009
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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
Arm II: Placebo Comparator 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, urine, and nipple aspiration fluid samples from women with 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, nipple aspirate, 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 30 days.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy confirmed ductal carcinoma in situ (DCIS) and/or atypical ductal hyperplasia (ADH)
- DCIS and/or ADH with a component of invasive carcinoma allowed
Newly diagnosed disease
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
Total bilirubin normal
Not pregnant or nursing
Negative pregnancy test
Speaks English or Spanish
No significant active medical illness that, in the opinion of the investigator, would preclude study treatment
No history of or active liver disease
No allergy or sensitivity to cruciferous vegetables

PRIOR CONCURRENT THERAPY:

More than 3 months since prior oral antibiotics
At least 72 hours since prior and no other concurrent nutritional supplements or herbal remedies containing sulforaphane
No concurrent oral steroid therapy
No concurrent valproic acid or vorinostat

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	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Alysia Cox, BS 800-949-1004, ext. 57758 coxal@ohsu.edu

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jackilen Shannon, PhD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Knight Cancer Institute at Oregon Health and Science University ( John T. Vetto )
Study ID Numbers:	CDR0000634111, OHSU-4702, OHSU-LAY-01
Study First Received:	February 12, 2009
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00843167 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ
atypical ductal breast hyperplasia

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Precancerous Conditions
Skin Diseases
Breast Neoplasms
Carcinoma
Hyperplasia
Neoplasms
Pathologic Processes

Neoplasms by Site
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010