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Can a drug stop the agony of mouth sores during cancer therapy?

NCT ID NCT03387774

Symptom relief Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether ulinastatin, a drug that blocks certain enzymes, can reduce severe mouth sores caused by chemoradiotherapy in 179 patients with advanced nasopharyngeal cancer. Patients received either standard care or ulinastatin alongside their cancer treatment. The goal was to see if fewer patients developed painful, severe oral mucositis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ulinastatin
What this could lead to
If it works, this could provide a new way to reduce painful mouth sores during cancer treatment, improving patients' quality of life.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely confirmed. The drug may not significantly reduce severe mucositis compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

179 people

The number who actually took part.

Started

Jan 2018

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis * Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition) * Karnofsky Performance Status Scale between 80-100 * WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L * ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min * Sign the informed consent. Exclusion Criteria: * Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas * Younger than 18 years old or older than 70 years old * Pregnancy or lactation * Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes * Have suffered from other tumor or now suffering from other tumor * Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases * Refuse to give up smoking/drinking/betel chewing * suffering from other active infection diseases and in need of treatment.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma stomatitis ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral mucositis (ulcerative) due to radiation

Contacts and locations

Locations

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.