NCT05853692 Prevention of Oral Mucositis in Head and Neck Cancer.
| NCT ID | NCT05853692 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catholic University of the Sacred Heart |
| Condition | Oral Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-10-10 |
| Primary Completion | 2027-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2022-10-10 with a primary completion date of 2027-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05853692 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05853692 currently recruiting?
Yes, NCT05853692 is actively recruiting participants. Contact the research team at carlo.lajolo@unicatt.it for enrollment information.
Where is the NCT05853692 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05853692 clinical trial?
NCT05853692 is sponsored by Catholic University of the Sacred Heart. The trial plans to enroll 130 participants.