Oral Mucositis
Conditions
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.
Interventions
DEVICEZinc Gluconate
Three times a day (spray)
DEVICESodium Bicarbonate
Five times a day (rinse)
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The principal investigator will be encharged of generating the allocation sequence, of enrolling the participants and of assigning the interventions to the participants. The coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.
Intervention model description
The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Mucositis | One week after the end of Radiotherapy | Yes/No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Oral Mucositis Onset | From Day 0 to 2 months | Days |
| Severity of Oral Mucositis | One week after the end of Radiotherapy | Difference in Oral Mucositis Grade |
Countries
Italy
Contacts
CONTACTCarlo Lajolo, Prof.
Outcome results
None listed