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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA132236 | U.S. NIH Grant/Contract | View source | |
| P30CA069533 | U.S. NIH Grant/Contract | View source | |
| OHSU-4702 | Other Identifier | OHSU IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane Supplement | Experimental | Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. |
|
| Placebo | Placebo Comparator | Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| broccoli sprout extract | Dietary Supplement | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline and End of Study (up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Compliance | For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant. | Baseline and end of study (up to 8 weeks) |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Jackilen Shannon, PhD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26511489 | Derived | 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. | |
| 26329135 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| |||||||||||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | µM/mM creatinine | Baseline and end of study (up to 8 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jackilen Shannon | Oregon Health & Science University | 541-706-6861 | shannoja@ohsu.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011230 | Precancerous Conditions |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| placebo |
| Other |
Given orally |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: Given orally
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Log 2 (H-score) | Baseline and end of study (up to 8 weeks) |
|
|
|
| Primary | 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. | PBMCs available pre-/post-intervention. | Posted | Mean | Standard Error | pmol/min/mg protein | Baseline and End of Study (up to 8 weeks) |
|
|
|
| Secondary | Treatment Compliance | For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant. | Posted | Number | participants | Baseline and end of study (up to 8 weeks) |
|
|
|
| 0 |
| 27 |
| 8 |
| 27 |
| EG001 | Placebo | Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. placebo: Given orally | 0 | 27 | 9 | 27 |
| Gas/Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Taste Alteration | Nervous system disorders | Systematic Assessment |
|
| Bruising | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tingling tongue sensation | Nervous system disorders | Systematic Assessment |
|
| Feeling tired | Psychiatric disorders | Systematic Assessment | The participant thinks it might be due to stress or these pills |
|
| More sleep | Nervous system disorders | Systematic Assessment |
|
| Sleeping less | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Arthritic pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Allergy | Immune system disorders | Systematic Assessment |
|
| Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heartburn | Cardiac disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
|