Preventing oral mucositis in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Gel X, a zinc gluconate-based spray, in preventing oral mucositis in patients undergoing radiotherapy for head and neck cancer. It compares the incidence of oral mucositis in patients using Gel X to those using sodium bicarbonate. The study aims to demonstrate that Gel X not only reduces the occurrence of oral mucositis but also alleviates pain and accelerates healing if mucositis occurs. Patients will self-apply the treatment as part of their care regimen.

Why it matters

Who can join: the full rules

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

Where it's running

• Catholic University of the Sacred Hearth
  Roma, Italy, Italy Recruiting

Study contacts

• Study coordinator: Carlo Lajolo, Prof.
• Email: carlo.lajolo@unicatt.it
• Phone: +393401004585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.