Trial Information

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

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