Prevention of Oral Mucositis in Head and Neck Cancer.

Launched by CATHOLIC UNIVERSITY OF THE SACRED HEART · May 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Gel X spray, which contains zinc gluconate, to see if it can help prevent a painful condition known as Oral Mucositis (OM) in patients receiving radiation therapy for head and neck cancers. Oral Mucositis happens when the tissues in the mouth become inflamed and can develop sores, causing discomfort and affecting eating and speaking. The researchers want to find out if Gel X is more effective at reducing the occurrence of OM compared to a common mouth rinse made of Sodium Bicarbonate.

To participate in this trial, patients need to be diagnosed with certain types of head and neck cancers and must be undergoing radiation therapy. They should also be able to apply the Gel X spray on their own. Patients who have allergies to any ingredients in Gel X or have certain neurological conditions that affect their ability to use the product cannot participate. If you join the trial, you may receive either Gel X or the Sodium Bicarbonate rinse, and the study will monitor how well these treatments work in preventing or reducing the pain of Oral Mucositis.

Gender

ALL

Eligibility criteria

• 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