Breast CancerPhase 2NCT00843167

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

A Phase 2 study testing broccoli sprout extract in people with Breast Cancer and Precancerous Condition, run by OHSU Knight Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia. Read more about this study

Who is it for?: Ages 21 to 120 years, women only
Conditions the study is for: Breast Cancer, Precancerous Condition
What is being tested?: broccoli sprout extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Dec 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 120 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnostic mammogram
English speaking

Who cannot join

Pregnancy (as determined by urine human chorionic gonadotropin (hCG) test)
No biopsy referral after diagnostic mammogram
Patient reported breast feeding
Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
History of or active liver disease or baseline total bilirubin greater than institutional upper limit of normal
Patient reported allergy or sensitivity to cruciferous vegetables

Show all 12Show fewer

Use of oral antibiotics within three months prior to randomization
Oral steroid therapy at enrollment
Current therapy with valproate acid or SAHA
Current use of nutrient supplements or herbal remedies containing sulforaphane and unwillingness or inability to quit 72 hours prior to randomization and for the duration of the trial
Radiation for currently-diagnosed disease prior to or during study supplementation
Chemotherapy for currently-diagnosed disease prior to or during study supplementation

Trial locations and contacts

1 site in 1 country.

United States1 site

Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098

Other trials in United States

About this study

Official title: Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)

RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia.

PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.

Read the detailed description

OBJECTIVES:

To determine the correlation between supplemental sulforaphane (broccoli sprout extract) dose and concentrations of sulforaphane and its metabolites in blood and urine samples from women positive for cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
To determine the effect of this supplement on biomarkers of prognosis in these patients.
To determine the effect of this supplement on HDAC inhibition in peripheral blood cell and normal and cancerous breast tissue samples from these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

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

Blood and urine samples are collected at baseline and after completion of study treatment for laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or lumpectomy) also undergo breast tissue sample collection at baseline and at the time of surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and apoptosis (TUNEL assay).

Patients complete questionnaires at baseline and periodically during study about their dietary history, family history, cruciferous vegetable intake, adverse events, and dietary and medication changes.

After completion of study therapy, patients are followed at/around 30 days.

Conditions: Breast Cancer, Precancerous Condition
Being tested: broccoli sprout extract, placebo
Keywords: mammography, biopsy, ductal breast carcinoma in situ, atypical ductal breast hyperplasia
Medical subject headings: Breast Neoplasms, Precancerous Conditions, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

broccoli sprout extractDietary supplement
Given orally
placeboOther
Given orally

Study groups in NCT00843167
Study group	Role	What they receive
Sulforaphane Supplement	Experimental	Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. Receives: Dietary Supplement: broccoli sprout extract
Placebo	Placebo comparator	Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy
Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.
Measured: Baseline and end of study (up to 8 weeks)
Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy
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.
Measured: Baseline and end of study (up to 8 weeks)
Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy
PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.
Measured: Baseline and End of Study (up to 8 weeks)

Secondary outcomes (1)

Treatment Compliance
For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.
Measured: Baseline and end of study (up to 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Dec 2013

First posted13 Feb 2009 (estimated)
Study startAug 2009
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00843167
Sponsor's protocol ID: CDR0000634111
Other IDs: R21CA132236, P30CA069533, OHSU-4702
Status last verified: Oct 2015
First submitted: 12 Feb 2009
Last updated: 27 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 26511489
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.
PubMed 26329135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)
ClinicalTrials.gov ID: NCT00843167
Acronym / sponsor ID: CDR0000634111
Conditions: Breast Cancer, Precancerous Condition
Keywords: mammography, biopsy, ductal breast carcinoma in situ, atypical ductal breast hyperplasia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Aug 2009
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 13 Feb 2009 (estimated)
Results: Posted 24 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia.

Detailed description

OBJECTIVES:

To determine the correlation between supplemental sulforaphane (broccoli sprout extract) dose and concentrations of sulforaphane and its metabolites in blood and urine samples from women positive for cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
To determine the effect of this supplement on biomarkers of prognosis in these patients.
To determine the effect of this supplement on HDAC inhibition in peripheral blood cell and normal and cancerous breast tissue samples from these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

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

After completion of study therapy, patients are followed at/around 30 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sulforaphane Supplement	Experimental	Dietary Supplement: broccoli sprout extractPatients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
Placebo	Placebo comparator	Other: placeboPatients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.

Who may qualify

Ages: 21 to 120 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnostic mammogram
English speaking

Key exclusion criteria (12 listed)

Pregnancy (as determined by urine human chorionic gonadotropin (hCG) test)
No biopsy referral after diagnostic mammogram
Patient reported breast feeding
Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
History of or active liver disease or baseline total bilirubin greater than institutional upper limit of normal

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
broccoli sprout extractGiven orally	Dietary supplement	Sulforaphane Supplement
placeboGiven orally	Other	Placebo

Primary outcome

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)
Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.
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)
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.
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)
PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.

1 secondary outcome

Treatment Compliance
Time frame: Baseline and end of study (up to 8 weeks)

Results and safety

Results posted to the registry on 24 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sulforaphane Supplement	27	24
Placebo	27	19

Primary outcome: 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). Mean (Standard Error). Unit: µM/mM creatinine

Measure	Sulforaphane Supplement n = 27	Placebo n = 27
Value	1.00 (0.334)	-0.05 (0.02)

Primary outcome: 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). Least squares mean (95% Confidence Interval). Unit: Log 2 (H-score)

Measure	Benign Tissue; Ki-67 n = 48	DCIS Tissue; Ki-67 n = 19	Invasive Ductal Carcinoma Tissue; Ki-67 n = 13
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)

Population analysed: 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.

Primary outcome: 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). Mean (Standard Error). Unit: pmol/min/mg protein

Measure	Sulforaphane Supplement n = 23	Placebo n = 24
Value	-80.39 (48.53)	27.52 (32.58)

Population analysed: PBMCs available pre-/post-intervention.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sulforaphane Supplement	0 of 27 (0%)	8 of 27 (29.6%)	Not reported
Placebo	0 of 27 (0%)	9 of 27 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26511489Atwell 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.
Derived from this study: PubMed 26329135Zhang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jackilen Shannon, PhD principal investigator

OHSU Knight Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing broccoli sprout extract in people with Breast Cancer and Precancerous Condition, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00843167, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.