Prevention of Oral Mucositis in Head and Neck Cancer.

Last updated: March 17, 2026
Sponsor: Catholic University of the Sacred Heart
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mucositis

Canker Sores

Treatment

Zinc Gluconate

Sodium Bicarbonate

Clinical Study ID

NCT05853692
ID 4576
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, salivaryglands, undergoing local radiotherapy as an adjuvant to surgical resection

  • Patients able self-apply the product.

Exclusion

Exclusion Criteria:

  • Patients with documented contraindication to any of the components of "Gel X" (thereincluded 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 theability to self-apply the treatment

  • Patients participating to other clinical studies

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Zinc Gluconate
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
June 10, 2028

Connect with a study center

  • Catholic University of the Sacred Hearth

    Roma, Italy 00168
    Italy

    Active - Recruiting

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