Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2022-10-10
2026-06-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
The coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.
Study Groups
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Test
The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)
Zinc Gluconate
Three times a day (spray)
Control
The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)
Sodium Bicarbonate
Five times a day (rinse)
Interventions
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Zinc Gluconate
Three times a day (spray)
Sodium Bicarbonate
Five times a day (rinse)
Eligibility Criteria
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Inclusion Criteria
* 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 any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
* Patients participating to other clinical studies
18 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Carlo Lajolo
Prof.
Locations
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Catholic University of the Sacred Hearth
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ID 4576
Identifier Type: -
Identifier Source: org_study_id
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