NCT00843167

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2009

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 24, 2015

Completed
Last Updated

April 27, 2017

Status Verified

October 1, 2015

Enrollment Period

4.3 years

First QC Date

February 12, 2009

Results QC Date

December 30, 2014

Last Update Submit

April 25, 2017

Conditions

Breast CancerPrecancerous Condition

Keywords

mammographybiopsyductal breast carcinoma in situatypical ductal breast hyperplasia

Outcome Measures

Primary Outcomes (3)

  • Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy

    Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.

    Baseline and end of study (up to 8 weeks)

  • Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy

    Ki-67 was measured through immunohistochemistry method. A modified H-score was recorded, which involved semi-quantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate staining, and 3 strong staining) and percentage of positive cells. The range of the H-score was 0-300. The maximum score indicates the strongest expression, the minimum score indicates no expression of positive tumor area.

    Baseline and end of study (up to 8 weeks)

  • Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy

    PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.

    Baseline and End of Study (up to 8 weeks)

Secondary Outcomes (1)

  • Treatment Compliance

    Baseline and end of study (up to 8 weeks)

Study Arms (2)

Sulforaphane Supplement

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

Placebo

PLACEBO COMPARATOR

Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.

Other: placebo

Interventions

broccoli sprout extractDIETARY_SUPPLEMENT

Given orally

Sulforaphane Supplement
placeboOTHER

Given orally

Placebo

Eligibility Criteria

Age21 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic mammogram
  • English speaking

You may not qualify if:

  • Pregnancy (as determined by urine human chorionic gonadotropin (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (2)

  • Atwell LL, Zhang Z, Mori M, Farris P, Vetto JT, Naik AM, Oh KY, Thuillier P, Ho E, Shannon J. Sulforaphane Bioavailability and Chemopreventive Activity in Women Scheduled for Breast Biopsy. Cancer Prev Res (Phila). 2015 Dec;8(12):1184-1191. doi: 10.1158/1940-6207.CAPR-15-0119. Epub 2015 Oct 28.

    PMID: 26511489DERIVED

  • Zhang Z, Atwell LL, Farris PE, Ho E, Shannon J. Associations between cruciferous vegetable intake and selected biomarkers among women scheduled for breast biopsies. Public Health Nutr. 2016 May;19(7):1288-95. doi: 10.1017/S136898001500244X. Epub 2015 Sep 2.

    PMID: 26329135DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPrecancerous ConditionsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

Title
Dr. Jackilen Shannon
Organization
Oregon Health & Science University
shannoja@ohsu.edu
541-706-6861

Study Officials

  • Jackilen Shannon, PhD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 27, 2017

Results First Posted

February 24, 2015

Record last verified: 2015-10

Locations

US(1)