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Mouth spray may stop radiation burns in cancer patients

NCT ID NCT07538934

Prevention Sponsor: YE ZHANG 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests if a spray called Kangfu Spray can prevent severe mouth sores in people with oral cancer who are getting radiation therapy. About 140 participants will either get the spray plus standard mouth care, or standard care alone. The goal is to see if the spray reduces the number of people who develop painful, high-grade mouth sores.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

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 80 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: * Histologically confirmed oral malignancy. * Age 18 to 80 years. * Karnofsky Performance Status (KPS) score \>=70. * Planned to receive definitive or postoperative adjuvant intensity-modulated radiotherapy (IMRT), with or without concurrent chemoradiotherapy, after multidisciplinary team evaluation. * Adequate organ function, including white blood cell count \>=2.0 x 10\^9/L, absolute neutrophil count \>=1.0 x 10\^9/L, platelet count \>=80 x 10\^9/L, hemoglobin \>=90 g/L, serum creatinine \<=1.5 x upper limit of normal (ULN) or creatinine clearance \>=50 mL/min, total bilirubin \<=1.5 x ULN, and AST/ALT \<=2.5 x ULN. * Able to understand and comply with study procedures. * Written informed consent provided. Exclusion Criteria: * Known allergy to Kangfu Spray or severe allergic predisposition. * Uncontrolled immune-related oral mucosal disease or prior related immune mucosal disease. * Pregnancy or breastfeeding. * Prior radiotherapy to the head and neck region. * Any severe concomitant disease or condition that, in the investigator's judgment, makes the participant unsuitable for participation.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced oral mucositis Mouth Neoplasms oral cavity cancer

As listed by the trial registrant

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

Oral malignancy Radiation-induced oral mucositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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