Prevention of Oral Mucositis in Head and Neck Cancer.

Not Applicable

Recruiting

• Conditions: Oral Mucositis
• Interventions: Device: Zinc Gluconate; Device: Sodium Bicarbonate

• Registration Number: NCT05853692
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2023-04-07
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11
• Primary Completion: 2025-10-10
• Study Completion: 2026-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose
• Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection
• Patients able self-apply the product.

Exclusion Criteria

• Patients with documented contraindication to any of the components of "Gel X" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors
• Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
• Patients participating to other clinical studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Zinc Gluconate	The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)
Control	Sodium Bicarbonate	The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)

Primary Outcome Measures

Name	Time	Method
Oral Mucositis	One week after the end of Radiotherapy	Yes/No

Secondary Outcome Measures

Name	Time	Method
Time of Oral Mucositis Onset	From Day 0 to 2 months	Days
Severity of Oral Mucositis	One week after the end of Radiotherapy	Difference in Oral Mucositis Grade

Trial Locations

Locations (1)

Catholic University of the Sacred Hearth; 🇮🇹 Roma, Italy