Preventing oral mucositis in head and neck cancer patients
Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
This study tests if a zinc spray can help prevent painful mouth sores in patients with head and neck cancer who are getting radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Roma, Italy) |
| Trial ID | NCT05853692 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with head and neck cancer who are receiving local radiotherapy and can self-apply the treatment.
Not a fit: Patients with contraindications to any components of Gel X or those with neurological or psychiatric conditions affecting their ability to self-apply the treatment may not benefit.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of oral mucositis, improving the quality of life for head and neck cancer patients undergoing radiotherapy.
How similar studies have performed: While the specific approach of using Gel X is novel, similar studies have shown that interventions targeting oral mucositis can be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma, Italy
- Catholic University of the Sacred Hearth — Roma, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Carlo Lajolo, Prof.
- Email: carlo.lajolo@unicatt.it
- Phone: +393401004585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.