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RECRUITING
NCT05853692
NA

Prevention of Oral Mucositis in Head and Neck Cancer.

Sponsor: Catholic University of the Sacred Heart

View on ClinicalTrials.gov

Summary

Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure. Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations. The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.

Official title: Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2022-10-10

Completion Date

2028-06-10

Last Updated

2026-03-19

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Zinc Gluconate

Three times a day (spray)

DEVICE

Sodium Bicarbonate

Five times a day (rinse)

Locations (1)

Catholic University of the Sacred Hearth

Roma, Italy, Italy