Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach

Sponsor

University of Milan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04858100

Collaborator

(none)

120

Enrollment

Location

Arms

60.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.

Condition or Disease	Intervention/Treatment	Phase
Leukoplakia, Oral	Procedure: Surgical excision of the lesion Other: Wait and see approach	N/A

Detailed Description

Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset.

A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias.

The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or prolonging the onset of potential oral squamous cell carcinoma. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial

Actual Study Start Date :

Feb 25, 2021

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Each patient will receive the surgical excision of the lesion and subsequent follow-up	Procedure: Surgical excision of the lesion The surgical removal of the lesion will follow these steps: local anesthesia excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having 5 mm-free margins silk or resorbable suture for wound closure The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam. The patient will receive a 3-6 month follow-up according to the clinical and histopathological case.
Active Comparator: Wait and see Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.	Other: Wait and see approach The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit.

Arm

Intervention/Treatment

Experimental: Surgery

Each patient will receive the surgical excision of the lesion and subsequent follow-up

Procedure: Surgical excision of the lesion

The surgical removal of the lesion will follow these steps: local anesthesia excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having 5 mm-free margins silk or resorbable suture for wound closure The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam. The patient will receive a 3-6 month follow-up according to the clinical and histopathological case.

Active Comparator: Wait and see

Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.

Other: Wait and see approach

The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit.

Outcome Measures

Primary Outcome Measures

Oral cancer incidence [every 3 or 6 months (according to the clinical case) up to 5 years]
Number of patients who will develop oral squamous cell carcinoma

Secondary Outcome Measures

Time to malignant transformation from diagnosis [every 3 or 6 months (according to clinical case) up to 5 years]
Period of time required to develop malignancy
Quality of life after surgical excision [month 1 and month 6]
To evaluate the quality of life of patients affected by leukoplakia and treated with surgical excision, via Functional Intraoral Glasgow Scale (FIGS) questionnaire. FIGS is a simple point scale used to assess a patient's ability to speak, chew and swallow. Each of these functions is scored independently on a scale of 1-5, five being no disability and one meaning the patient has an inability to speak, chew, or swallow.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

OL diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis
Subjects' age: 18 years or older
Lesions' size: 3 cm maximum longitudinal size of the single lesion
Lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries.
Ability to understand and to sign a written informed consent document

Exclusion Criteria:

Previous oral cancer
Head and neck radiotherapy
Subjects under the age of 18
Subjects affected by PVL (proliferative verrucous leukoplakia)
High-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries