Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia

Cairo University (CU)

Status and phase: Enrolling; Phase 2

Conditions: Oral Leukoplakia

Treatments: Drug: Placebo; Drug: Metformin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT07387900

OMED 3.7.2

Details and patient eligibility

About

There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.

While metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.

Enrollment: 34 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients over 21 years.
• Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.
• Lesions with mild to moderate degree of dysplasia.
• Patients who agree to sign a written consent after understanding the nature of the study.

Exclusion criteria

• Patients with lesions showing sever degree of dysplasia.
• Patients who have cardiovascular, lung, Renal, Liver diseases
• Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)
• Patients on H2 blocker & proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)
• Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.
• Patients on Retinoid, green tea supplements or another natural products therapy
• Patients with other accompanying oral lesions
• Pregnant or Lactating females

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

34 participants in 2 patient groups, including a placebo group

Topical and systemic metformin

Experimental group

Treatment:

Drug: Metformin Hydrochloride

Topical and systemic Placebo

Placebo Comparator group

Treatment:

Drug: Placebo