At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed or suspected oral premalignant lesion (atypical hyperplasia, dysplasia, leukoplakia, or erythroplakia) ≥12 mm that has not been biopsied in past 6 weeks
- ✓Lesion must be either early (high-risk site with atypical cells/mild dysplasia/hyperplastic leukoplakia) or advanced (moderate or severe dysplasia excluding CIS)
- ✓Age >18 years
- ✓Life expectancy >12 weeks with Zubrod performance status 0 or 1
- ✕Chemotherapy, immunotherapy, hormonal therapy (except HRT), or radiotherapy within 3 weeks of baseline
- ✕Not recovered from acute toxic effects of prior chemotherapy, immunotherapy, hormonal therapy, or radiotherapy
- ✕Planned concurrent chemotherapy, radiotherapy, hormonal therapy (except HRT), or immunotherapy during study
- ✕History of hypersensitivity to sulindac, COX-2 inhibitors, NSAIDs, or salicylates
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Multi-Center International Double-Blind Placebo Controlled Randomized Study of Sulindac, a Pan-Cox Inhibitor, in Oral Premalignant Lesions
In Brief
A clinical study evaluating sulindac and Placebo for Leukoplakia, Oral and Benign Neoplasms. Completed, enrolled 63 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this study is to see if a drug called sulindac can prevent the development of changes in the mouth that are related to oral pre-cancer growths (oral epithelial dysplasia) or oral cancer. Sulindac is an anti-inflammatory drug that has already been tested in people with arthritis (inflammation of a joint). This study is being done by Memorial Sloan-Kettering Cancer Center in New York, Amrita Institute of Medical Sciences and Research Center in Cochin, India, and Regional Cancer Centre (RCC) in Trivandrum, India.
Study Details
Timeline
Interventions
Sulindac 150 mg po bid x 24 weeks
Placebo bid x 24 weeks