NCT05853692

Prevention of Oral Mucositis in Head and Neck Cancer.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DEVICE	Zinc Gluconate	Three times a day (spray)
DEVICE	Sodium Bicarbonate	Five times a day (rinse)

Timeline

• Start date: 2022-10-10
• Primary completion: 2027-10-10
• Completion: 2028-06-10
• First posted: 2023-05-11
• Last updated: 2026-03-19

Locations

1 site across 1 country: Italy