Trial Outcomes & Findings for Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy (NCT NCT00843167)
NCT ID: NCT00843167
Last Updated: 2017-04-27
Results Overview
Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline and end of study (up to 8 weeks)
Results posted on
2017-04-27
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Treatment Period
STARTED
|
27
|
27
|
|
Treatment Period
COMPLETED
|
24
|
19
|
|
Treatment Period
NOT COMPLETED
|
3
|
8
|
|
Follow-up
STARTED
|
24
|
24
|
|
Follow-up
Completed Final Visit
|
24
|
24
|
|
Follow-up
COMPLETED
|
24
|
24
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
5
|
|
Treatment Period
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Baseline characteristics by cohort
| Measure |
Sulforaphane Supplement
n=27 Participants
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
n=27 Participants
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of study (up to 8 weeks)Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.
Outcome measures
| Measure |
Sulforaphane Supplement
n=27 Participants
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
n=27 Participants
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
Invasive Ductal Carcinoma Tissue; Ki-67
Sulforaphane Supplement= 7, Placebo= 6
|
|---|---|---|---|
|
Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy
|
1.00 µM/mM creatinine
Standard Error 0.334
|
-0.05 µM/mM creatinine
Standard Error 0.02
|
—
|
PRIMARY outcome
Timeframe: Baseline and end of study (up to 8 weeks)Population: 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.
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.
Outcome measures
| Measure |
Sulforaphane Supplement
n=48 Participants
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
n=19 Participants
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
Invasive Ductal Carcinoma Tissue; Ki-67
n=13 Participants
Sulforaphane Supplement= 7, Placebo= 6
|
|---|---|---|---|
|
Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy
Sulforaphane Supplement
|
-1.39 Log 2 (H-score)
Interval -2.23 to -0.55
|
0.42 Log 2 (H-score)
Interval -1.18 to 2.02
|
0.98 Log 2 (H-score)
Interval -3.89 to 5.85
|
|
Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy
Placebo
|
0.23 Log 2 (H-score)
Interval -0.61 to 1.07
|
-0.48 Log 2 (H-score)
Interval -1.69 to 0.72
|
0.28 Log 2 (H-score)
Interval -3.22 to 3.78
|
PRIMARY outcome
Timeframe: Baseline and End of Study (up to 8 weeks)Population: PBMCs available pre-/post-intervention.
PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.
Outcome measures
| Measure |
Sulforaphane Supplement
n=23 Participants
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
n=24 Participants
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
Invasive Ductal Carcinoma Tissue; Ki-67
Sulforaphane Supplement= 7, Placebo= 6
|
|---|---|---|---|
|
Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy
|
-80.39 pmol/min/mg protein
Standard Error 48.53
|
27.52 pmol/min/mg protein
Standard Error 32.58
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of study (up to 8 weeks)For treatment compliance, participants who take \>=80% of the prescribed pills will be considered to be treatment-compliant.
Outcome measures
| Measure |
Sulforaphane Supplement
n=27 Participants
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
n=27 Participants
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
Invasive Ductal Carcinoma Tissue; Ki-67
Sulforaphane Supplement= 7, Placebo= 6
|
|---|---|---|---|
|
Treatment Compliance
|
19 participants
|
16 participants
|
—
|
Adverse Events
Sulforaphane Supplement
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sulforaphane Supplement
n=27 participants at risk
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
n=27 participants at risk
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
18.5%
5/27
|
18.5%
5/27
|
|
Gastrointestinal disorders
Gas/Flatulence
|
3.7%
1/27
|
14.8%
4/27
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27
|
7.4%
2/27
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/27
|
3.7%
1/27
|
|
Nervous system disorders
Headache
|
3.7%
1/27
|
11.1%
3/27
|
|
Nervous system disorders
Taste Alteration
|
0.00%
0/27
|
7.4%
2/27
|
|
Musculoskeletal and connective tissue disorders
Bruising
|
3.7%
1/27
|
3.7%
1/27
|
|
Nervous system disorders
Tingling tongue sensation
|
0.00%
0/27
|
3.7%
1/27
|
|
Psychiatric disorders
Feeling tired
|
0.00%
0/27
|
3.7%
1/27
|
|
Nervous system disorders
More sleep
|
0.00%
0/27
|
3.7%
1/27
|
|
Nervous system disorders
Sleeping less
|
0.00%
0/27
|
3.7%
1/27
|
|
Nervous system disorders
Insomnia
|
0.00%
0/27
|
3.7%
1/27
|
|
Musculoskeletal and connective tissue disorders
Arthritic pain
|
3.7%
1/27
|
3.7%
1/27
|
|
Immune system disorders
Allergy
|
0.00%
0/27
|
3.7%
1/27
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
3.7%
1/27
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
3.7%
1/27
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.7%
1/27
|
0.00%
0/27
|
|
Cardiac disorders
Heartburn
|
3.7%
1/27
|
0.00%
0/27
|
Additional Information
Dr. Jackilen Shannon
Oregon Health & Science University
Phone: 541-706-6861
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place