Can a stem cell spray stop radiation mouth pain?
NCT ID NCT07312656
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an oral spray made from stem cell exosomes to prevent severe mouth sores in head and neck cancer patients undergoing radiation. 200 participants will use the spray three times daily, starting a week before radiation and continuing for two weeks after. The goal is to see if it reduces the number of patients who develop painful, high-grade mouth ulcers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mesenchymal stem cell-derived exosomes
- What this could lead to
- If it works, this could provide a new way to prevent painful mouth sores caused by radiation therapy, improving quality of life for head and neck cancer patients.
- What could go wrong
- This is a Phase 2 trial, so it is still early. The treatment may not reduce severe mouth sores more than standard care, and side effects from the exosome spray are not yet fully known.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Histologically or cytologically confirmed malignant tumor of the head and neck; 2. Age 18-75 years; 3. Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and/or oropharynx; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months. 5. White blood cell≥3.0×10\^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10\^9/ L 6. Transaminases≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal; 7. Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min; 8. Cardiac: Electrocardiogram (ECG) without clinically significant abnormalities; 9. Intact oral mucosa before initiation of radiotherapy. Absence of active oral infections or severe periodontal disease before initiation of radiotherapy; 10. Signed informed consent form. Exclusion Criteria: 1. Previous radiotherapy to the head and neck region; 2. Head and neck surgery within the preceding 4 weeks; 3. Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks; 4. Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV); 5. Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance \<30 mL/min); 6. Active systemic infection requiring antimicrobial therapy; 7. Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring ongoing immunosuppressive treatment; 8. Severe psychiatric disorders that may impair the ability to provide informed consent or adhere to the study protocol; 9. Using other oral mucosal protective agents or anti-inflammatory medications that cannot be discontinued. Long-term use of immunosuppressants or corticosteroids at a prednisone-equivalent dose \>10 mg/day; 10. Individuals unable to comprehend the study requirements or comply with study procedures; 11. Any other condition that, in the judgment of the investigator, would render the patient unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer