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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA213123 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research study involves taking an experimental anti-cancer dietary supplement called Sulforaphane (SF) or a placebo (product without any supplement content) over a period of twelve months in order to determine if it is a useful dietary supplement for prevention of lung cancer in humans.
The main goals of this research study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane (Study Drug) | Experimental | Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane |
|
| Placebo | Placebo Comparator | Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane | Dietary Supplement | Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bronchial Dysplasia Index at 12 Months | To explore if daily oral dose of 120 micromole SF can modulate the changes in bronchial dysplasia from endoscopic biopsies in former smokers at high risk for lung cancer. All bronchial biopsies were formalin fixed, paraffin embedded, and H&E stained for subsequent morphologic evaluation and classification defined by the World Health Organization The scale to score the biopsy: 1= normal; 2= reserve cell hyperplasia; 3 = squamous metaplasia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ; and 8 = invasive carcinoma. The higher the score the worse the possible outcome. | 12 months |
| Cell Proliferation Marker Ki-67 | The primary outcome focuses on the changes of bronchial dysplasia index with cell proliferation marker Ki-67. The determination if a daily oral dose of 120 micromole SF for 12 months can modulate the changes of bronchial dysplasia index, cell proliferation marker Ki-67. Besides the inhibition of tumor incidence and multiplicity, the use of sulforaphane can inhibit cellular proliferation markers such as Ki-67 and induction of apoptosis hallmarks of tumorigenesis. Ki-67 will be quantified as % positive cells in two slides of each tissue block. First, we calculate the average values of each of the 3 IHC markers over 6 tissue blocks within each bronchoscopy per patient separately for pre- and post-treatment. The primary analysis for these continuous measures will be a linear regression predicting post-treatment score by treatment group, controlling for pre-treatment score. | 12 months |
| Apoptosis Marker TUNEL | The determination if a daily oral dose of 120 micromole SF for 12 months can modulate the changes of bronchial dysplasia index, in apoptosis marker TUNEL in bronchial biopsies in former smokers at high risk for lung cancer. TUNEL will be quantified as % positive cells in two slides of each tissue block. First, we calculate the average values of each of the 3 IHC markers over 6 tissue blocks within each bronchoscopy per patient separately for pre- and post-treatment. The primary analysis for these continuous measures will be a linear regression predicting post-treatment score by treatment group, controlling for pre-treatment score. |
| Measure | Description | Time Frame |
|---|---|---|
| Upregulated Genes Associated With Lung Cancer Risk in Bronchial Brushing Samples | Gene set variation analysis (GSVA) algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is upregulated in lung cancer (LC) tissue, the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against LC. | 12 Months |
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Inclusion Criteria:
Man or woman 55-75 years of age.
Patients with normal endobronchial biopsy findings or pre-cancerous lesions at baseline will be eligible for the study. Pre-cancerous lesions include (a) reserve cell hyperplasia, (b) squamous metaplasia, (c) mild dysplasia, (d) moderate dysplasia, and (e) severe dysplasia.
A former smoker who has a history of smoking with ≥30 pack-years, quits smoking within the past 10 years, and has ≥1 year sustained abstinence from smoking.
Female subjects must be of non-child bearing potential or must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication) if of childbearing potential.
Male and female subjects of childbearing potential must be willing to use adequate barrier methods of contraception from the time starting with the screening visit through 30 days after the last dose of study therapy.
Abstinence is acceptable if this is the established and preferred contraception for the subject.
Generally healthy with liver enzyme and blood count values within the ranges shown below on the blood sample drawn at the baseline screening visit. Specifically:
White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x ULN (upper limits of normal) AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN BUN and serum creatinine ≤ 1.5 x ULN Serum pregnancy test Negative
The presence of airflow obstruction on spirometry (GOLD II or greater, Forced Expiratory Volume in the first second (FEV1) <80%) Chronic Obstructive Pulmonary Disease (COPD); and/or any emphysema on CT scan.
Participants must have a Southwest Oncology Group (SWOG) performance status of 0-2
Participants must be able and willing to undergo a bronchoscopy before and after treatment for 12 months.
Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance within institutional and regulatory guidelines.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian-Min Yuan, MD, PhD | Univesity of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulforaphane (Study Drug) | Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane Sulforaphane: Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables. |
| FG001 | Placebo | Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner Placebo: Inactive ingredients |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We conducted telephone screening interview for eligibility on 105 subjects, of whom 67 were potentially eligible for the study. Of the 67 who visited our research clinic, 47 passed the physical examination and clinical tests. We randomized 43 participants after 4 eligible subjects declined to participate in the study. Of those randomized, 37 (17 in the SFN arm and 20 in the placebo arm) completed the entire course of the study and 7 (5 in the SFN arm and 2 in the placebo arm) withdrew.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulforaphane (Study Drug) | Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane Sulforaphane: Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Baseline in Bronchial Dysplasia Index at 12 Months | To explore if daily oral dose of 120 micromole SF can modulate the changes in bronchial dysplasia from endoscopic biopsies in former smokers at high risk for lung cancer. All bronchial biopsies were formalin fixed, paraffin embedded, and H&E stained for subsequent morphologic evaluation and classification defined by the World Health Organization The scale to score the biopsy: 1= normal; 2= reserve cell hyperplasia; 3 = squamous metaplasia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ; and 8 = invasive carcinoma. The higher the score the worse the possible outcome. | Mean change from pre to post treatment (95%) confidence interval. | Posted | Mean | Standard Deviation | score | 12 months |
|
1 year treatment, 1year post treatment
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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 (Study Drug) | Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane Sulforaphane: Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bad taste | Gastrointestinal disorders | Systematic Assessment |
Limited study size due to the circumstances of COVID19 impact on in person research studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jian-Min Yuan M.D., Ph.D. | University of Pittsburgh Cancer Institute | 412-864-7889 | yuanj@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2019 | May 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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Double Blind
| Placebo | Drug | Inactive ingredients |
|
| 12 months |
| Apoptosis Marker Caspase-3 | The determination if a daily oral dose of 120 micromole SF for 12 months can modulate the changes of bronchial dysplasia index, in apoptosis marker Caspase-3 in bronchial biopsies in former smokers at high risk for lung cancer. Caspase-3 will be quantified as % positive cells in two slides of each tissue block. First, we calculate the average values of each of the 3 IHC markers over 6 tissue blocks within each bronchoscopy per patient separately for pre- and post-treatment. The primary analysis for these continuous measures will be a linear regression predicting post-treatment score by treatment group, controlling for pre-treatment score. | 12 months |
| Downregulated Genes Associated With Lung Cancer Risk in Bronchial Brushing Samples | Gene set variation analysis (GSVA) algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is downregulated in LC, the enhancing effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against LC. | 12 months |
| Upregulated Genes Associated With Lung Pre-Malignant Lesions (PML) in Bronchial Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is upregulated in lung pre-malignant lesions (PML), the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against PML. | 12 months |
| Downregulated Genes Associated With Lung Pre-malignant Lesions (PML) in Bronchial Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is downregulated in PML, the enhancing effect of sulforaphane (SFN) treatment on such genes also suggests a protective effect against PML. | 12 months |
| Upregulated Genes Associated With Risk of Lung Cancer in Nasal Brushing Samples | Similarly, GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is upregulated in lung cancer (LC), the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against LC. | 12 months |
| Downregulated Genes Associated With Risk of Lung Cancer in Nasal Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is downregulated in lung cancer (LC), the enhancing effect of sulforaphane (SFN) treatment on such genes also suggests a protective effect against LC. | 12 months |
| Upregulated Genes Associated With Risk of Lung Pre-malignant Lesions Cancer (PML) in Nasal Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is upregulated in PML. the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against PML risk. | 12 months |
| Downregulated Genes Associated With Risk of Lung Pre-malignant Lesions (PML) in Nasal Brushing Samples | Similarly, GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is downregulated in PML, the overexpression effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against PML | 12 months |
| Overall Number of Adverse Events That Occurred in the Study Population as Assessed by CTCAE v4.0 | To determine the safety and toxicity of daily oral dose of 120 micromole SF in former smokers at high risk for lung cancer by monitoring and recording any potential SF-related adverse events (both expected and unexpected events). The severity is calculated by five grades: 1=mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. Events are assigned to categories of unrelated, possibly elated, probably related, and related. | 12 Months |
| Withdrawal by Subject |
|
Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner Placebo: Inactive ingredients |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education levels | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner Placebo: Inactive ingredients |
|
|
|
| Primary | Cell Proliferation Marker Ki-67 | The primary outcome focuses on the changes of bronchial dysplasia index with cell proliferation marker Ki-67. The determination if a daily oral dose of 120 micromole SF for 12 months can modulate the changes of bronchial dysplasia index, cell proliferation marker Ki-67. Besides the inhibition of tumor incidence and multiplicity, the use of sulforaphane can inhibit cellular proliferation markers such as Ki-67 and induction of apoptosis hallmarks of tumorigenesis. Ki-67 will be quantified as % positive cells in two slides of each tissue block. First, we calculate the average values of each of the 3 IHC markers over 6 tissue blocks within each bronchoscopy per patient separately for pre- and post-treatment. The primary analysis for these continuous measures will be a linear regression predicting post-treatment score by treatment group, controlling for pre-treatment score. | Mean changes from the baseline and pre to post treatment. | Posted | Mean | 95% Confidence Interval | counts per µm^2 | 12 months |
|
|
|
|
| Primary | Apoptosis Marker TUNEL | The determination if a daily oral dose of 120 micromole SF for 12 months can modulate the changes of bronchial dysplasia index, in apoptosis marker TUNEL in bronchial biopsies in former smokers at high risk for lung cancer. TUNEL will be quantified as % positive cells in two slides of each tissue block. First, we calculate the average values of each of the 3 IHC markers over 6 tissue blocks within each bronchoscopy per patient separately for pre- and post-treatment. The primary analysis for these continuous measures will be a linear regression predicting post-treatment score by treatment group, controlling for pre-treatment score. | TUNEL positive nuclei (counts/µm2) Mean (95% CI) changes from baseline and pre- to post-treatment | Posted | Mean | 95% Confidence Interval | counts/µm2 | 12 months |
|
|
|
|
| Primary | Apoptosis Marker Caspase-3 | The determination if a daily oral dose of 120 micromole SF for 12 months can modulate the changes of bronchial dysplasia index, in apoptosis marker Caspase-3 in bronchial biopsies in former smokers at high risk for lung cancer. Caspase-3 will be quantified as % positive cells in two slides of each tissue block. First, we calculate the average values of each of the 3 IHC markers over 6 tissue blocks within each bronchoscopy per patient separately for pre- and post-treatment. The primary analysis for these continuous measures will be a linear regression predicting post-treatment score by treatment group, controlling for pre-treatment score. | Caspase-3 positive cytoplasm (% of total cells examined) | Posted | Mean | 95% Confidence Interval | percent of cells | 12 months |
|
|
|
|
| Secondary | Upregulated Genes Associated With Lung Cancer Risk in Bronchial Brushing Samples | Gene set variation analysis (GSVA) algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is upregulated in lung cancer (LC) tissue, the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against LC. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | Relative score from -1 to +1 | 12 Months | Upregulated genes with lung cancer risk | Upregulated genes with lung cancer risk |
|
|
|
|
| Secondary | Downregulated Genes Associated With Lung Cancer Risk in Bronchial Brushing Samples | Gene set variation analysis (GSVA) algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is downregulated in LC, the enhancing effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against LC. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | Relative score from -1 to +1 | 12 months | upregulated gene with lung cancer risk | upregulated gene with lung cancer risk |
|
|
|
|
| Secondary | Upregulated Genes Associated With Lung Pre-Malignant Lesions (PML) in Bronchial Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is upregulated in lung pre-malignant lesions (PML), the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against PML. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | relative score from -1 to +1 | 12 months | Upregulated genes with PML risk | Upregulated genes with PML risk |
|
|
|
|
| Secondary | Downregulated Genes Associated With Lung Pre-malignant Lesions (PML) in Bronchial Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in bronchial brushing samples. If a gene is downregulated in PML, the enhancing effect of sulforaphane (SFN) treatment on such genes also suggests a protective effect against PML. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | relative score from -1 to +1 | 12 months | upregulated gene with PML cancer risk | upregulated gene with PML cancer risk |
|
|
|
|
| Secondary | Upregulated Genes Associated With Risk of Lung Cancer in Nasal Brushing Samples | Similarly, GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is upregulated in lung cancer (LC), the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against LC. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | relative score from -1 to +1 | 12 months | Nasal upregulated genes with LC risk | Nasal upregulated genes with LC risk |
|
|
|
|
| Secondary | Downregulated Genes Associated With Risk of Lung Cancer in Nasal Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is downregulated in lung cancer (LC), the enhancing effect of sulforaphane (SFN) treatment on such genes also suggests a protective effect against LC. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | relative score from -1 to +1 | 12 months | Nasal upregulated genes with LC risk | Nasal upregulated genes with LC risk |
|
|
|
|
| Secondary | Upregulated Genes Associated With Risk of Lung Pre-malignant Lesions Cancer (PML) in Nasal Brushing Samples | GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is upregulated in PML. the inhibitory effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against PML risk. | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | relative score from -1 to +1 | 12 months | Nasal upregulated genes with LC risk | Nasal upregulated genes with LC risk |
|
|
|
|
| Secondary | Downregulated Genes Associated With Risk of Lung Pre-malignant Lesions (PML) in Nasal Brushing Samples | Similarly, GSVA algorithm was used to calculate gene set enrichment scores in nasal brushing samples. If a gene is downregulated in PML, the overexpression effect of sulforaphane (SFN) treatment on such genes suggests a protective effect against PML | Due to poor quality of RNA and missing data on the gene expression, we excluded 5 subjects in the sulforaphane group and 4 subjects in the placebo group. The final analysis for this secondary outcome included 12 subjects in the sulforaphane and 16 subjects in the placebo group. | Posted | Mean | Standard Deviation | relative score from -1 to +1 | 12 months | Nasal upregulated genes with LC risk | Nasal upregulated genes with LC risk |
|
|
|
|
| Secondary | Overall Number of Adverse Events That Occurred in the Study Population as Assessed by CTCAE v4.0 | To determine the safety and toxicity of daily oral dose of 120 micromole SF in former smokers at high risk for lung cancer by monitoring and recording any potential SF-related adverse events (both expected and unexpected events). The severity is calculated by five grades: 1=mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. Events are assigned to categories of unrelated, possibly elated, probably related, and related. | Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer. The number of patients included those who dropped out from the study. | Posted | Number | events | 12 Months |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 21 |
| 21 |
| EG001 | Placebo | Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner Placebo: Inactive ingredients | 0 | 22 | 0 | 22 | 22 | 22 |
| Belching | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Distension | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Stomachache | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Mood Alteration | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Others | General disorders | Systematic Assessment |
|
Not provided
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Baseline: Moderate Intensity positive nuclei |
|
| Baseline: Strong intensity positive nuclei |
|
| Pre to Post Treatment: All positive nuclei |
|
| Pre to Post Treatment: Weak-intensity positive nuclei |
|
| Pre to Post Treatment: Moderate-intensity positive nuclei |
|
| Pre to Post Treatment: Strong-intensity positive nuclei |
|
Weak-intensity positive nuclei. Mean (95%CI) baseline. |
| Analysis of Covariance |
| 0.780 |
Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo. |
| Equivalence |
2-sided P-value in the analysis |
| Moderate intensity positive nuclei. Mean (95%CI) changes in baseline. | Analysis of Covariance | 0.733 | Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo. | Equivalence | 2-sided P-value in the analysis |
| Strong-Intensity positive nuclei. Mean (95%CI) changes in baseline. | Analysis of Covariance | 0.751 | Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo. | Equivalence | 2-sided P-value in the analysis |
| All positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of Ki-67 positive nuclei | 0.014 | Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo. | Equivalence | 2-sided P-value in the analysis |
| Week intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Covariance | Analysis of Covariance adjustment age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker | 0.056 | Equivalence | 2-sided P-value in the analysis |
| Moderate Intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker | 0.028 | Equivalence | 2-sided P-value in the analysis |
| Strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker | 0.004 | Equivalence | 2-sided P-value in the analysis |
| Baseline: Moderate-intensity positive nuclei |
|
| Baseline: Strong-intensity positive nuclei |
|
| Pre to Post Treatment: All positive nuclei |
|
| Pre to Post Treatment: Weak-intensity positive nuclei |
|
| Pre to Post Treatment: Moderate-intensity positive nuclei |
|
| Pre to Post Treatment: Strong-intensity positive nuclei |
|
| Weak-intensity positive nuclei. Mean (95%CI) baseline. | Analysis of Covariance | 0.413 | Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo. | Equivalence | 2-sided P-value in the analysis |
| Moderate Intensity positive nuclei. Mean (95%CI) at baseline. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei | 0.338 | Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) at baseline Moderate-intensity positive nuclei. TUNEL positive (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Strong-intensity positive nuclei. Mean (95%CI) baseline. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei | 0.547 | Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| All positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei | 0.291 | Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies | Equivalence | used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Weak-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei | 0.552 | Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Moderate-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei | 0.205 | Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Strong-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei | 0.295 | Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Baseline: Moderate-intensity positive cells |
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| Baseline: Strong-intensity positive cells |
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| Pre to Post Treatment: All positive cells |
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| Pre to Post Treatment: Weak-intensity positive cells |
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| Pre to Post Treatment: Moderate-intensity positive cells |
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| Pre to Post Treatment: Strong-intensity positive cells |
|
| weak intensity positive nuclei. Mean (95%CI) at baseline. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.242 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Moderate intensity positive nuclei. Mean (95%CI) at baseline. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.985 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | -sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Strong intensity positive nuclei. Mean (95%CI) at baseline. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.547 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| All positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.778 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker. |
| Weak intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.685 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker |
| Moderate intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.469 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | -sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker |
| strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment. | Analysis of Covariance | Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells | 0.052 | Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo. | Equivalence | 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarke |
This analysis was focused on the gene set that were found to be upregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.
This analysis was focused on the gene set that were found to be upregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.
This analysis was focused on the gene set that were found to be downregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated downregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.
| Unrelated Grade 3 |
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| Unrelated Grade 4 |
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| Unrelated Grade 5 |
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| Possibly Related Grade 1 |
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| Possibly Related Grade 2 |
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| Possibly Related Grade 3 |
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| Possibly Related Grade 4 |
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| Possibly Related Grade 5 |
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| Probably Related Grade 1 |
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| Probably Related Grade 2 |
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| Probably Related Grade 3 |
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| Probably Related Grade 4 |
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| Probably Related Grade 5 |
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| Related Grade 1 |
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| Related Grade 2 |
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| Related Grade 3 |
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| Related Grade 4 |
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| Related Grade 5 |
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| All adverse events Grade 1 |
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| All adverse events Grade 2 |
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| All adverse events Grade 3 |
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| All adverse events Grade 4 |
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| All adverse events Grade 5 |
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| Fisher Exact |
| 0.131 |
For attribution by treatment group. |
| Equivalence |
Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer |