Status:
COMPLETED
Aspirin Mouthwash in Treating Patients With Oral Leukoplakia
Lead Sponsor:
Institute of Head and Neck Studies and Education, United Kingdom
Conditions:
Precancerous Condition
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 aspir...
Detailed Description
OBJECTIVES: * To determine if oral topical acetylsalicylic acid mouthwash achieves modulation of COX-1, COX-2, and prostaglandin in oral dysplasia tissues in patients with oral leukoplakia. * To dete...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01238185
Start Date
February 1 2010
End Date
October 1 2011
Last Update
August 12 2013
Active Locations (2)
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1
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
2
Institute of Head and Neck Studies and Education
Coventry, England, United Kingdom, CV2 2DX