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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05853692
Other study ID # ID 4576
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 10, 2022
Est. completion date June 10, 2026

Study information

Verified date May 2023
Source Catholic University of the Sacred Heart
Contact Carlo Lajolo, Prof.
Phone +393401004585
Email carlo.lajolo@unicatt.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date June 10, 2026
Est. primary completion date October 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Zinc Gluconate
Three times a day (spray)
Sodium Bicarbonate
Five times a day (rinse)

Locations

Country Name City State
Italy Catholic University of the Sacred Hearth Roma

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral Mucositis Yes/No One week after the end of Radiotherapy
Secondary Time of Oral Mucositis Onset Days From Day 0 to 2 months
Secondary Severity of Oral Mucositis Difference in Oral Mucositis Grade One week after the end of Radiotherapy
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