Clinical trial · Interventional
Aspirin Mouthwash in Treating Patients With Oral Leukoplakia
Oral Topical Cyclooxygenase Inhibitor (Aspirin) Mouthwash for Treatment of Oral Dysplasia
NCT01238185CI-TRIAL-00011723completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash in treating patients with oral leukoplakia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylsalicylic acid | Drug | Aspirin | ALIAS |
| biopsy | Procedure | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- PGE2 levels as assessed by enzyme immunosorbent assay
- measure
- COX-1 and COX-2 mRNA as assessed by qRT-PCR
- measure
- COX-1 and COX-2 protein expression as assessed by immunohistochemistry and quantified by immunoblotting to determine whether COX inhibition in oral dysplasia tissues is actually possible by use of the mouthwash formulation
Secondary outcomes (5)
- measure
- Comparison of WHO histological grade and clinical size of dysplastic lesions before and after treatment and assessment of proliferating cell nuclear antigen
- measure
- Tolerability and possible oral and other adverse effects using a questionnaire
- measure
- VEGF mRNA expression as assessed by qRT-PCR
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Clinically diagnosed oral leukoplakia requiring a tissue biopsy for histological diagnosis * Attending the outpatient clinic PATIENT CHARACTERISTICS: * Not nursing * No known or suspected sensitivity to aspirin or other nonsteroidal anti-inflammatory drugs * No diagnosis of asthma or angioedema * No contraindications, including any of the following: * Active peptic ulceration or a history of peptic ulceration * Hemophilia or a history of bleeding disorders * Gout or a history of gout PRIOR CONCURRENT THERAPY: * No concurrent regular use of aspirin for heart disease or other reasons * No other concurrent nonsteroidal anti-inflammatory drugs
References
Publications (0)
Data not yet available
No reference posted for this study.