Aspirin Mouthwash in Treating Patients With Oral Leukoplakia

August 9, 2013 updated by: Institute of Head and Neck Studies and Education, United Kingdom

Oral Topical Cyclooxygenase Inhibitor (Aspirin) Mouthwash for Treatment of Oral Dysplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 determine if this drug achieves alteration of histopathology and gene and protein expression in tissue.
  • To determine if this drug achieves aspirin-induced tissue changes relating to altered tumor biology.
  • To assess local and general tolerability and safety of this drug in these patients.

OUTLINE: All patients undergo tissue biopsy for histological diagnosis. Patients without a histological diagnosis of precancerous oral dysplasia undergo routine follow-up. Patients with a histological diagnosis of precancerous oral dysplasia are sequentially allocated to 1 of 4 treatment groups.

  • Group 1: Patients receive acetylsalicylic acid mouthwash (one 75 mg tablet dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
  • Group 2: Patients receive acetylsalicylic acid mouthwash (two 75 mg tablets of acetylsalicylic acid dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
  • Group 3: Patients receive acetylsalicylic acid mouthwash (one 300 mg tablet of acetylsalicylic acid dissolved in 250 mL of water) twice daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.
  • Group 4: Patients receive acetylsalicylic acid mouthwash (one 300 mg tablet of acetylsalicylic acid dissolved in 250 mL of water) three times daily for 4-6 weeks, gargling for 60 seconds then expectorate it fully, before planned definitive surgical excision.

At the time of definitive surgical excision, the patient is asked to gargle with the last dose of acetylsalicylic acid mouthwash just before being anesthetized. A small biopsy of the dysplasia lesion is taken and examined for immediate effects of the acetylsalicylic acid mouthwash on the dysplasia lesion. The surgically excised tissue is treated in the same way as the initial biopsy tissue (i.e., half being used for routine histology to confirm the diagnosis and the other half for research purposes). Tissue samples are analyzed via enzyme immunosorbent assay, qRT-PCR, immunoblotting, ELISA, immunohistochemistry, gene array analysis, and microvessel density analysis.

Patients complete a questionnaire assessing local and general tolerability as well as adverse effects during the period of use of the mouthwash.

After completion of study treatment, patients are followed periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TT
        • University of Birmingham
      • Coventry, England, United Kingdom, CV2 2DX
        • Institute of Head and Neck Studies and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Head and Neck Studies and Education, United Kingdom

Investigators

  • Principal Investigator: Hisham Mehanna, MD, Institute of Head and Neck Studies and Education, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INHANSE-ASPOD
  • CDR0000688122 (Registry Identifier: PDQ (Physician Data Query))
  • ISRCTN31503555 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))
  • EU-21083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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