Prevention of Oral Mucositis in Head and Neck Cancer.

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Device: Zinc Gluconate
* Device: Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day) | Device: Zinc Gluconate<br>* Three times a day (spray)<br>|
| Active Comparator: Control<br>The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day) | Device: Sodium Bicarbonate<br>* Five times a day (rinse)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Mucositis | Yes/No | One week after the end of Radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Oral Mucositis Onset | Days | From Day 0 to 2 months | 
| Severity of Oral Mucositis | Difference in Oral Mucositis Grade | One week after the end of Radiotherapy |