Prevention of Oral Mucositis in Head and Neck Cancer.

Catholic University of the Sacred Heart130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Oral Mucositis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oral Mucositis

Yes/No

Time frame: One week after the end of Radiotherapy

Secondary Outcomes

Time of Oral Mucositis Onset

Days

Time frame: From Day 0 to 2 months

Severity of Oral Mucositis

Difference in Oral Mucositis Grade