Lung CancerPhase 2NCT03232138

Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers

A Phase 2 study testing Sulforaphane in people with Lung Cancer, run by Jian-Min Yuan, MD at 1 site in United States.

Completed

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

Trial summary

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. Read more about this study

Who is it for?: Ages 55 to 75 years
Conditions the study is for: Lung Cancer
What is being tested?: Sulforaphane
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 25 Jan 2018to 17 Feb 2023
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 55 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

Carcinoma in situ or invasive cancer on baseline endobronchial biopsy.
A malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Severe lung disease or inability to undergo two bronchoscopies.
Had pneumonia or acute bronchitis for at least 2 weeks prior to enrollment.
Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2 minutes) premature ventricular contractions are not exclusionary.
Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or congestive heart failure, or any serious medical condition which would preclude a patient from undergoing a bronchoscopy or would jeopardize the goals of the study.

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Hypoxemia (less than 90% saturation with supplemental oxygen).
Prior chemotherapy or thoracic radiation within the past 5 years.
Woman who is pregnant or plan to be pregnant in next 12 months, or is breast feeding or plan to begin breast feeding in next 12 months.
Life expectancy of < 12 months.
Have a history of irritable bowel disease such as Crohn's disease and ulcerative colitis.

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Randomized Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers

The main goals of this research study are:

To learn about the effects of giving Sulforaphane (SF) to former smokers who are still at high risk of developing cancer due to their smoking history and whether or not their condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.
To learn whether Sulforaphane (SF) might reverse some of the lung cell changes associated with future development of lung cancer.

Conditions: Lung Cancer
Being tested: Sulforaphane, Placebo
Keywords: Sulforaphane, Chemoprevention, Former Smokers
Medical subject headings: Lung Neoplasms, Smoking Cessation

What participants receive

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

SulforaphaneDietary supplement
Also called Avmacol®
Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.
PlaceboDrug
Inactive ingredients

Study groups in NCT03232138
Study group	Role	What they receive
Sulforaphane (Study Drug)	Experimental	Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane Receives: Dietary Supplement: Sulforaphane
Placebo	Placebo comparator	Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner Receives: Drug: Placebo

What is being measured

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

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 Months

Timeline

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

25 Jan 201817 Feb 2023

First posted27 Jul 2017
Study start25 Jan 2018
Primary completion17 Feb 2023
Study completion17 Feb 2023

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 (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03232138
Sponsor's protocol ID: STUDY19040278
Other IDs: R01CA213123
Status last verified: Nov 2024
First submitted: 21 Jul 2017
Last updated: 17 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Yuan JM, Kensler TW, Dacic S, Hartman DJ, Wang R, Balogh PA, Sufka P, Turner MA, Fuhrer K, Seigh L, Pham YT, Adams-Haduch J, Valacchi G, Singh SV, Herman JG, Wilson DO. Randomized Phase II Clinical Trial of Sulforaphane in Former Smokers at High Risk for Lung Cancer. Cancer Prev Res (Phila). 2025 Jun 2;18(6):335-345. doi: 10.1158/1940-6207.CAPR-24-0386.
PubMed 40041932

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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers
ClinicalTrials.gov ID: NCT03232138
Acronym / sponsor ID: STUDY19040278
Conditions: Lung Cancer
Keywords: Sulforaphane, Chemoprevention, Former Smokers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Jian-Min Yuan, MDUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 25 Jan 2018 (actual)
Primary completion: 17 Feb 2023 (actual)
Study completion: 17 Feb 2023 (actual)
First posted: 27 Jul 2017 (actual)
Results: Posted 17 Dec 2024

Clinical summary

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

The main goals of this research study are:

To learn about the effects of giving Sulforaphane (SF) to former smokers who are still at high risk of developing cancer due to their smoking history and whether or not their condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.
To learn whether Sulforaphane (SF) might reverse some of the lung cell changes associated with future development of lung cancer.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sulforaphane (Study Drug)	Experimental	Dietary Supplement: SulforaphaneSulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane
Placebo	Placebo comparator	Drug: PlaceboPlacebo (containing no active drug) four tablets 2 times per day with breakfast and dinner

Who may qualify

Ages: 55 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (11 listed)

Carcinoma in situ or invasive cancer on baseline endobronchial biopsy.
A malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Severe lung disease or inability to undergo two bronchoscopies.
Had pneumonia or acute bronchitis for at least 2 weeks prior to enrollment.
Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2 minutes) premature ventricular contractions are not exclusionary.

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
SulforaphaneAlso: Avmacol®Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.	Dietary supplement	Sulforaphane (Study Drug)
PlaceboInactive ingredients	Drug	Placebo

Primary outcome

Change From Baseline in Bronchial Dysplasia Index at 12 Months
Time frame: 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.
Cell Proliferation Marker Ki-67
Time frame: 12 months
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.
Apoptosis Marker TUNEL
Time frame: 12 months
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.
Apoptosis Marker Caspase-3
Time frame: 12 months
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.

9 secondary outcomes

Upregulated Genes Associated With Lung Cancer Risk in Bronchial Brushing Samples
Time frame: 12 Months
Downregulated Genes Associated With Lung Cancer Risk in Bronchial Brushing Samples
Time frame: 12 months
Upregulated Genes Associated With Lung Pre-Malignant Lesions (PML) in Bronchial Brushing Samples
Time frame: 12 months
Downregulated Genes Associated With Lung Pre-malignant Lesions (PML) in Bronchial Brushing Samples
Time frame: 12 months
Upregulated Genes Associated With Risk of Lung Cancer in Nasal Brushing Samples
Time frame: 12 months
Downregulated Genes Associated With Risk of Lung Cancer in Nasal Brushing Samples
Time frame: 12 months
Upregulated Genes Associated With Risk of Lung Pre-malignant Lesions Cancer (PML) in Nasal Brushing Samples
Time frame: 12 months
Downregulated Genes Associated With Risk of Lung Pre-malignant Lesions (PML) in Nasal Brushing Samples
Time frame: 12 months
Overall Number of Adverse Events That Occurred in the Study Population as Assessed by CTCAE v4.0
Time frame: 12 Months

Results and safety

Results posted to the registry on 17 Dec 2024, 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 (Study Drug)	21	17
Placebo	22	20

Primary outcome: Change From Baseline in Bronchial Dysplasia Index at 12 Months

Time frame: 12 months. Mean (Standard Deviation). Unit: score

Measure	Sulforaphane (Study Drug) n = 17	Placebo n = 20
Pre treatment	1.67 (0.38)	1.62 (0.41)
Post treatment	1.55 (0.44)	1.48 (0.37)

Sulforaphane (Study Drug): Mean Difference (Final Values): 0.22 (95% CI 0.03 to 0.41), p = 0.452, ANCOVA
Placebo: Mean Difference (Final Values): 0.12 (95% CI -0.04 to 0.28), p = 0.452, ANCOVA

Population analysed: Mean change from pre to post treatment (95%) confidence interval.

Primary outcome: Cell Proliferation Marker Ki-67

Time frame: 12 months. Mean (95% Confidence Interval). Unit: counts per µm^2

Measure	Sulforaphane (Study Drug) n = 17	Placebo n = 20
Baseline: All positive nuclei	26.07 (18.64 to 33.51)	27.75 (24.90 to 34.61)
Baseline: Weak-Intensity positive nuclei	11.71 (8.85 to 14.57)	12.21 (9.57 to 14.85)
Baseline: Moderate Intensity positive nuclei	6.70 (4.42 to 8.97)	7.22 (5.12 to 9.32)
Baseline: Strong intensity positive nuclei	7.67 (4.61 to 10.72)	8.32 (5.51 to 11.14)
Pre to Post Treatment: All positive nuclei	-5.27 (-18.13 to 7.59)	18.03 (7.18 to 28.88)
Pre to Post Treatment: Weak-intensity positive nuclei	-0.50 (-6.44 to 5.26)	7.48 (2.55 to 12.41)
Pre to Post Treatment: Moderate-intensity positive nuclei	-1.16 (-4.76 to 2.44)	4.61 (1.57 to 7.64)
Pre to Post Treatment: Strong-intensity positive nuclei	-3.41 (-7.67 to 0.85)	5.93 (2.24 to 9.52)

Sulforaphane (Study Drug) vs Placebo: p = 0.738, Analysis of Covariance
Sulforaphane (Study Drug) vs Placebo: p = 0.780, Analysis of Covariance
Sulforaphane (Study Drug) vs Placebo: p = 0.733, Analysis of Covariance

Population analysed: Mean changes from the baseline and pre to post treatment.

Primary outcome: Apoptosis Marker TUNEL

Time frame: 12 months. Mean (95% Confidence Interval). Unit: counts/µm2

Measure	Sulforaphane (Study Drug) n = 17	Placebo n = 20
Baseline: All positive nuclei	5.01 (4.28 to 5.75)	4.57 (3.89 to 5.25)
Baseline: Weak-intensity positive nuclei	2.73 (2.33 to 3.13)	2.51 (2.15 to 2.88)
Baseline: Moderate-intensity positive nuclei	1.78 (1.52 to 2.04)	1.61 (1.37 to 1.85)
Baseline: Strong-intensity positive nuclei	0.50 (0.37 to 0.63)	0.45 (0.33 to 0.57)
Pre to Post Treatment: All positive nuclei	-0.21 (-0.96 to 0.53)	0.35 (-0.27 to 0.96)
Pre to Post Treatment: Weak-intensity positive nuclei	-0.05 (-0.43 to 0.34)	0.12 (-0.27 to 0.44)
Pre to Post Treatment: Moderate-intensity positive nuclei	-0.10 (-0.38 to 0.18)	0.16 (-0.08 to 0.39)
Pre to Post Treatment: Strong-intensity positive nuclei	-0.05 (-0.18 to 0.09)	0.05 (-0.06 to 0.17)

Sulforaphane (Study Drug) vs Placebo: p = 0.377, Analysis of Covariance
Sulforaphane (Study Drug) vs Placebo: p = 0.413, Analysis of Covariance
Sulforaphane (Study Drug) vs Placebo: p = 0.338, Analysis of Covariance

Population analysed: TUNEL positive nuclei (counts/µm2) Mean (95% CI) changes from baseline and pre- to post-treatment

Primary outcome: Apoptosis Marker Caspase-3

Time frame: 12 months. Mean (95% Confidence Interval). Unit: percent of cells

Measure	Sulforaphane (Study Drug) n = 17	Placebo n = 20
Baseline: All positive cells	4.46 (2.36 to 6.57)	2.96 (1.02 to 4.90)
Baseline: Weak-intensity positive cells	4.18 (2.31 to 6.04)	2.69 (0.97 to 4.41)
Baseline: Moderate-intensity positive cells	0.25 (-0.01 to 0.50)	0.25 (0.01 to 0.49)
Baseline: Strong-intensity positive cells	0.04 (-0.002 to 0.08)	0.02 (-0.02 to 0.06)
Pre to Post Treatment: All positive cells	-1.28 (-2.64 to 0.08)	-1.00 (-2.15 to 0.96)
Pre to Post Treatment: Weak-intensity positive cells	-1.19 (-2.44 to 0.06)	-0.83 (-1.88 to 0.23)
Pre to Post Treatment: Moderate-intensity positive cells	-0.07 (-0.21 to 0.08)	-0.14 (-0.26 to -0.02)
Pre to Post Treatment: Strong-intensity positive cells	-0.01 (-0.02 to -0.001)	-0.03 (-0.04 to -0.02)

Sulforaphane (Study Drug) vs Placebo: p = 0.295, Analysis of Covariance
Sulforaphane (Study Drug) vs Placebo: p = 0.242, Analysis of Covariance
Sulforaphane (Study Drug) vs Placebo: p = 0.985, Analysis of Covariance

Population analysed: Caspase-3 positive cytoplasm (% of total cells examined)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year treatment, 1year post treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sulforaphane (Study Drug)	0 of 21 (0%)	21 of 21 (100%)	0 of 21
Placebo	0 of 22 (0%)	22 of 22 (100%)	0 of 22

Limitations and caveats (from the sponsor): Limited study size due to the circumstances of COVID19 impact on in person research studies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40041932Yuan JM, Kensler TW, Dacic S, Hartman DJ, Wang R, Balogh PA, Sufka P, Turner MA, Fuhrer K, Seigh L, Pham YT, Adams-Haduch J, Valacchi G, Singh SV, Herman JG, Wilson DO. Randomized Phase II Clinical Trial of Sulforaphane in Former Smokers at High Risk for Lung Cancer. Cancer Prev Res (Phila). 2025 Jun 2;18(6):335-345. doi: 10.1158/1940-6207.CAPR-24-0386.
Individual participant dataSharing planned: No

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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.

Jian-Min Yuan, MD, PhD principal investigator

Univesity of Pittsburgh

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 Sulforaphane in people with Lung Cancer, run by Jian-Min Yuan, MD 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 12 inclusion and 11 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 17 Dec 2024. 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 17 Dec 2024). 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 From Baseline in Bronchial Dysplasia Index at 12 Months (time frame: 12 months). The study lists 4 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 NCT03232138, which also lists 1 linked publication.

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 17 Dec 2024.