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

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ClinicalTrials.gov Identifier: NCT00843167
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : February 24, 2015
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jackie Shannon, OHSU Knight Cancer Institute

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

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

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 
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

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) ]
  Show Outcome Measure 1

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


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: 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 )
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: December 30, 2014
Results First Posted: February 24, 2015
Last Update Posted: April 27, 2017