Health TrialsbyHealthPanel

Prevention of Oral Mucositis in Head and Neck Cancer.

ConditionOral Mucositis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatholic University of the Sacred Heart

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zinc Gluconate

    Device

    Three times a day (spray)

  • Sodium Bicarbonate

    Device

    Five times a day (rinse)

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: TestExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oral Mucositis

Yes/No

Time frame
One week after the end of Radiotherapy

Secondary outcomes

1

Time of Oral Mucositis Onset

Days

Time frame
From Day 0 to 2 months
2

Severity of Oral Mucositis

Difference in Oral Mucositis Grade

Time frame
One week after the end of Radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Catholic University of the Sacred Heart

Lead sponsor

Source ClinicalTrials.gov
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