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NCT Number: NCT05853692

Prevention of Oral Mucositis in Head and Neck Cancer.

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.

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of the Sacred Hearth

Roma, Italy, 00168

Location status: Recruiting

Location contact

Carlo Lajolo, Prof.

CONTACT

[email protected]

+393356078354

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc Gluconate

Device

Three times a day (spray)

Sodium Bicarbonate

Device

Five times a day (rinse)

Primary outcomes

  1. Oral Mucositis

    Time frame: One week after the end of Radiotherapy

    Yes/No

Secondary outcomes

  1. Time of Oral Mucositis Onset

    Time frame: From Day 0 to 2 months

    Days

  2. Severity of Oral Mucositis

    Time frame: One week after the end of Radiotherapy

    Difference in Oral Mucositis Grade

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Lajolo, Prof.

CONTACT

[email protected]

+393401004585

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.

Acronym: OMHNC-1

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 11, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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