Prevention of Oral Mucositis in Head and Neck Cancer. (OMHNC-1)

Catholic University of the Sacred Heart

Status: Enrolling

Conditions: Oral Mucositis

Treatments: Device: Zinc Gluconate; Device: Sodium Bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT05853692

ID 4576

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Test

Experimental group

Description:

The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)

Treatment:

Device: Zinc Gluconate

Control

Active Comparator group

Description:

The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)

Treatment:

Device: Sodium Bicarbonate