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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):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00843167
First received: February 12, 2009
Last updated: October 20, 2015
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: Double Blind (Subject, 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
No text entered.

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

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.
No text entered.

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  
Number of Participants  
[units: participants]
 		  27     27     54  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     24     18     42  
>=65 years     3     9     12  
Age  
[units: years]
Mean (Standard Deviation) 		  53.5  (9.5)     55.3  (14.3)     54.4  (12.1)  
Gender  
[units: participants]
 		     
Female     27     27     54  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     1     1     2  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     1     1  
White     26     24     50  
More than one race     0     0     0  
Unknown or Not Reported     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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

4.  Secondary:   Treatment Compliance   [ Time Frame: Baseline and end of study (up to 8 weeks) ]
  Show Outcome Measure 4


  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):


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00843167     History of Changes
Other Study ID Numbers: CDR0000634111
R21CA132236 ( US NIH Grant/Contract Award Number )
P30CA069533 ( US NIH Grant/Contract Award Number )
OHSU-4702 ( Other Identifier: OHSU IRB )
Study First Received: February 12, 2009
Results First Received: December 30, 2014
Last Updated: October 20, 2015
Health Authority: United States: Federal Government