Prevention of Oral Mucositis in Head and Neck Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zinc Gluconate, Sodium Bicarbonate.
- Who it may be relevant to
- Registry conditions: Oral Mucositis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
Overview
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.
Interventions
- Device Zinc Gluconate
Three times a day (spray) - Device Sodium Bicarbonate
Five times a day (rinse)
Primary outcome measures
- Oral Mucositis [Time frame: One week after the end of Radiotherapy]
Secondary outcome measures (2)
- Time of Oral Mucositis Onset [Time frame: From Day 0 to 2 months]
- Severity of Oral Mucositis [Time frame: One week after the end of Radiotherapy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Catholic University of the Sacred Hearth — Roma
Identifiers
NCT: NCT05853692 · ID 4576