Clinical Trial: Aspirin Mouthwash in Treating Patients With Oral Leukoplakia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:

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: Pat
    Sponsor: Institute of Head and Neck Studies and Education, United Kingdom

    Current Primary Outcome:

    • 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


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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


    Original Secondary Outcome: Same as current

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: November 9, 2010
    Date Started: February 2010
    Date Completion:
    Last Updated: August 9, 2013
    Last Verified: November 2010