Aspirin Mouthwash in Treating Patients With Oral Leukoplakia

NCT01238185 | Completed Phase 1

• 4 other identifiers: INHANSE-ASPODCDR0000688122ISRCTN31503555EU-21083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 aspirin mouthwash in treating patients with oral leukoplakia.

Conditions

Precancerous Condition

Keywords

oral leukoplakia

Outcome Measures

Primary Outcomes (3)

• PGE2 levels as assessed by enzyme immunosorbent assay

• COX-1 and COX-2 mRNA as assessed by qRT-PCR

• 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)

• Comparison of WHO histological grade and clinical size of dysplastic lesions before and after treatment and assessment of proliferating cell nuclear antigen

• Tolerability and possible oral and other adverse effects using a questionnaire

• VEGF mRNA expression as assessed by qRT-PCR

• Protein expression as assessed by ELISA and immunohistochemistry for VEGFA

• Global gene response of dysplastic tissue as assessed by Affymetrix gene expression microarrays

Interventions

acetylsalicylic acid DRUG

gene expression analysis GENETIC

protein expression analysis GENETIC

laboratory biomarker analysis OTHER

questionnaire administration OTHER

biopsy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Head and Neck Studies and Education, United Kingdom: lead

Study Sites (2)

University of Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Institute of Head and Neck Studies and Education

Coventry, England, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Precancerous Conditions; Leukoplakia, Oral

Interventions

Aspirin; Gene Expression Profiling; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Leukoplakia; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Genetic Techniques; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Hisham Mehanna, MD

  Institute of Head and Neck Studies and Education, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2010-11

Locations

GB (2)