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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
Enrollment 54
Recruitment Details 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  
Arm/Group Title Sulforaphane Supplement Placebo
Hide Arm/Group Description

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

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

placebo: Given orally

Period Title: Treatment Period
Started 27 27
Completed 24 19
Not Completed 3 8
Reason Not Completed
Adverse Event             1             5
Withdrawal by Subject             2             3
Period Title: Follow-up
Started 24 24
Completed Final Visit 24 24
Completed 24 24
Not Completed 0 0
Arm/Group Title Sulforaphane Supplement Placebo Total
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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

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

placebo: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
53.5  (9.5) 55.3  (14.3) 54.4  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
27
 100.0%
27
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
1.Primary Outcome
Title Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy
Hide Description Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.
Time Frame Baseline and end of study (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Supplement Placebo
Hide Arm/Group Description:

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

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

placebo: Given orally

Overall Number of Participants Analyzed 27 27
Mean (Standard Error)
Unit of Measure: µM/mM creatinine
1.00  (0.334) -0.05  (0.02)
2.Primary Outcome
Title Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy
Hide Description 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.
Time Frame Baseline and end of study (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Maximum two observations (pre- and post- treatments) were expected per participant. Linear mixed effect models were used to calculate adjusted least square means (LSMEANS) and 95% confidence intervals,& to test the statistical significance of the difference between pre- and post- treatments within each group, as well as between treatment groups.
Arm/Group Title Benign Tissue; Ki-67 DCIS Tissue; Ki-67 Invasive Ductal Carcinoma Tissue; Ki-67
Hide Arm/Group Description:
Sulforaphane Supplement = 23, Placebo = 25
Sulforaphane Supplement= 6, Placebo = 13
Sulforaphane Supplement= 7, Placebo= 6
Overall Number of Participants Analyzed 48 19 13
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Log 2 (H-score)
Sulforaphane Supplement
-1.39
(-2.23 to -0.55)
0.42
(-1.18 to 2.02)
0.98
(-3.89 to 5.85)
Placebo
0.23
(-0.61 to 1.07)
-0.48
(-1.69 to 0.72)
0.28
(-3.22 to 3.78)
3.Primary Outcome
Title Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy
Hide Description PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.
Time Frame Baseline and End of Study (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
PBMCs available pre-/post-intervention.
Arm/Group Title Sulforaphane Supplement Placebo
Hide Arm/Group Description:

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

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

placebo: Given orally

Overall Number of Participants Analyzed 23 24
Mean (Standard Error)
Unit of Measure: pmol/min/mg protein
-80.39  (48.53) 27.52  (32.58)
4.Secondary Outcome
Title Treatment Compliance
Hide Description For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.
Time Frame Baseline and end of study (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Supplement Treatment
Hide Arm/Group Description:

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

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

placebo: Given orally

Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: participants
19 16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulforaphane Supplement Placebo
Hide Arm/Group Description

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

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

placebo: Given orally

All-Cause Mortality
Sulforaphane Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sulforaphane Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sulforaphane Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/27 (29.63%)   9/27 (33.33%) 
Cardiac disorders     
Heartburn   1/27 (3.70%)  0/27 (0.00%) 
Gastrointestinal disorders     
Bloating   5/27 (18.52%)  5/27 (18.52%) 
Gas/Flatulence   1/27 (3.70%)  4/27 (14.81%) 
Diarrhea   1/27 (3.70%)  2/27 (7.41%) 
Nausea/Vomiting   0/27 (0.00%)  1/27 (3.70%) 
Immune system disorders     
Allergy   0/27 (0.00%)  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders     
Bruising   1/27 (3.70%)  1/27 (3.70%) 
Arthritic pain   1/27 (3.70%)  1/27 (3.70%) 
Cramping   1/27 (3.70%)  0/27 (0.00%) 
Knee pain   1/27 (3.70%)  0/27 (0.00%) 
Shoulder pain   1/27 (3.70%)  0/27 (0.00%) 
Nervous system disorders     
Headache   1/27 (3.70%)  3/27 (11.11%) 
Taste Alteration   0/27 (0.00%)  2/27 (7.41%) 
Tingling tongue sensation   0/27 (0.00%)  1/27 (3.70%) 
More sleep   0/27 (0.00%)  1/27 (3.70%) 
Sleeping less   0/27 (0.00%)  1/27 (3.70%) 
Insomnia   0/27 (0.00%)  1/27 (3.70%) 
Psychiatric disorders     
Feeling tired  [1]  0/27 (0.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
[1]
The participant thinks it might be due to stress or these pills
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
Layout table for Results Point of Contact information
Name/Title: Dr. Jackilen Shannon
Organization: Oregon Health & Science University
Phone: 541-706-6861
EMail: shannoja@ohsu.edu
Layout table for additonal information
Responsible Party: Jackie Shannon, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00843167    
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