RecruitingNCT05853692OMHNC-1Updated Mar 19, 2026

Prevention of Oral Mucositis in Head and Neck Cancer.

An interventional study of Zinc Gluconate and Sodium Bicarbonate in Oral Mucositis, sponsored by Catholic University of the Sacred Heart. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 5 months after the study started (first participant enrolled Oct 2022, registered Apr 2023).
Started Oct 2022; still recruiting 4 years 1 month later.

Phase: Not applicable
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Conditions studied

Oral Mucositis

Browse trials for

Stomatitis 306

In context

Stomatitis

306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.

This study's planned enrollment of 130 is above the median of 60 across 276 interventional studies indexed under Stomatitis.

Browse Stomatitis studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

Browse Catholic University of the Sacred Heart studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients with documented 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication: A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 130 participants (estimated)

Study arms

Experimental
Test
The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)
Device: Zinc Gluconate
Active comparator
Control
The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)
Device: Sodium Bicarbonate

Interventions

DeviceZinc Gluconate
Three times a day (spray)
DeviceSodium Bicarbonate
Five times a day (rinse)

What researchers measure

Primary outcomes

Oral Mucositis
Yes/No
Time frame: One week after the end of Radiotherapy

Secondary outcomes

Time of Oral Mucositis Onset
Days
Time frame: From Day 0 to 2 months
Severity of Oral Mucositis
Difference in Oral Mucositis Grade
Time frame: One week after the end of Radiotherapy

Study locations

1 of 1 sites recruiting

Catholic University of the Sacred Hearth
Roma, Italy 00168, Italy
Recruiting
- Carlo Lajolo, Prof. · Contact · carlo.lajolo@unicatt.it · +393356078354
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Oct 2027, 60 months after the start.

Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 60 months is above that.

Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 7, 2023
First posted: May 11, 2023
StartActual: Oct 10, 2022
Primary completionEst.: Oct 10, 2027
CompletionEst.: Jun 10, 2028
Last update: Mar 19, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05853692
Lead sponsor: Catholic University of the Sacred Heart
Responsible party: Carlo Lajolo (Prof., Catholic University of the Sacred Heart) — Principal investigator
First posted: May 11, 2023
Start date: Oct 10, 2022
Primary completion: Oct 10, 2027 (estimated)
Completion: Jun 10, 2028 (estimated)
Last update: Mar 19, 2026

Study contacts

Carlo Lajolo, Prof.

Contact

carlo.lajolo@unicatt.it

+393401004585

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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