CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Age 55–75 years
  • Former smoker with ≥30 pack-year history, quit within past 10 years, and ≥1 year sustained abstinence
  • Normal endobronchial biopsy or pre-cancerous lesions (reserve cell hyperplasia, squamous metaplasia, mild/moderate/severe dysplasia)
  • Airflow obstruction (GOLD II or greater, FEV1 <80%), COPD, and/or emphysema on CT scan
Key exclusion· 10
  • Carcinoma in situ or invasive cancer on baseline endobronchial biopsy
  • Prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Severe lung disease or inability to undergo two bronchoscopies
  • Pneumonia or acute bronchitis within 2 weeks prior to enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03232138
NCT03232138Phase 2Completed

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

Jian-Min Yuan, MD·interventional·Posted Jul 27, 2017·Updated Dec 17, 2024

In Brief

A Phase 2 clinical trial evaluating Sulforaphane and Placebo for Lung Cancer. Completed, enrolled 43 participants across 1 site.

Detailed 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. The main goals of this research study are: 1. 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. 2. To learn whether Sulforaphane (SF) might reverse some of the lung cell changes associated with future development of lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 27, 2017
Enrollment StartJan 25, 2018
Primary CompletionFeb 17, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.9 years ago

Interventions

Sulforaphanedietary

Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.

Placebodrug

Inactive ingredients