Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Jackie Shannon, OHSU Knight Cancer Institute

ClinicalTrials.gov Identifier:

NCT00843167

First received: February 12, 2009

Last updated: April 25, 2017

Last verified: October 2015

History of Changes

Results First Received: December 30, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Breast Cancer Precancerous Condition
Interventions:	Dietary Supplement: broccoli sprout extract Other: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This clinical trial was conducted between 12/23/2008 to 3/27/2013 at Oregon Health and Science University’s (OHSU) Center for Women’s Health Breast Center in Portland, OR. English-speaking women were recruited to participate in the study based on the following inclusion criteria: ≥ 21 years, diagnostic mammogram with results that require biopsy.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sulforaphane Supplement	Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. broccoli sprout extract: Given orally
Placebo	Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally

Description

Sulforaphane Supplement

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

broccoli sprout extract: Given orally

Placebo

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

placebo: Given orally

Participant Flow for 2 periods

Period 1: Treatment Period

	Sulforaphane Supplement	Placebo
STARTED	27	27
COMPLETED	24	19
NOT COMPLETED	3	8
Adverse Event	1	5
Withdrawal by Subject	2	3

Period 2: Follow-up

	Sulforaphane Supplement	Placebo
STARTED	24	24
Completed Final Visit	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Sulforaphane Supplement	Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. broccoli sprout extract: Given orally
Placebo	Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally
Total	Total of all reporting groups

Description

Sulforaphane Supplement

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

broccoli sprout extract: Given orally

Placebo

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

placebo: Given orally

Total

Total of all reporting groups

Baseline Measures

	Sulforaphane Supplement	Placebo	Total
Overall Participants Analyzed [Units: Participants]	27	27	54

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%	0 0.0%	0 0.0%
Between 18 and 65 years	24 88.9%	18 66.7%	42 77.8%
>=65 years	3 11.1%	9 33.3%	12 22.2%

Age [Units: Years] Mean (Standard Deviation)	53.5 (9.5)	55.3 (14.3)	54.4 (12.1)

Sex: Female, Male [Units: Participants] Count of Participants
Female	27 100.0%	27 100.0%	54 100.0%
Male	0 0.0%	0 0.0%	0 0.0%

Race (NIH/OMB) [Units: Participants] Count of Participants
American Indian or Alaska Native	1 3.7%	1 3.7%	2 3.7%
Asian	0 0.0%	1 3.7%	1 1.9%
Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
Black or African American	0 0.0%	1 3.7%	1 1.9%
White	26 96.3%	24 88.9%	50 92.6%
More than one race	0 0.0%	0 0.0%	0 0.0%
Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Region of Enrollment [Units: Participants]
United States	27	27	54

Outcome Measures

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1. Primary:

Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy [ Time Frame: Baseline and end of study (up to 8 weeks) ]

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2. Primary:

Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy [ Time Frame: Baseline and end of study (up to 8 weeks) ]

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3. Primary:

Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy [ Time Frame: Baseline and End of Study (up to 8 weeks) ]

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4. Secondary:

Treatment Compliance [ Time Frame: Baseline and end of study (up to 8 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Jackilen Shannon
Organization: Oregon Health & Science University
phone: 541-706-6861
e-mail: shannoja@ohsu.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Jackie Shannon, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00843167 History of Changes
Other Study ID Numbers:	CDR0000634111 R21CA132236 ( U.S. NIH Grant/Contract ) P30CA069533 ( U.S. NIH Grant/Contract ) OHSU-4702 ( Other Identifier: OHSU IRB )
Study First Received:	February 12, 2009
Results First Received:	December 30, 2014
Last Updated:	April 25, 2017

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