Oral Mucositis (Ulcerative) Due to RadiationPhase 2NCT07312656
Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis
A Phase 2 study testing mesenchymal stem cell-derived exosomes in people with Oral Mucositis (Ulcerative) Due to Radiation, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Mucositis (Ulcerative) Due to Radiation
- What is being tested?
- mesenchymal stem cell-derived exosomes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed malignant tumor of the head and neck;
- Age 18-75 years;
- Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and/or oropharynx;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months.
- White blood cell≥3.0×10^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10^9/ L
- Transaminases≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal;
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- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min;
- Cardiac: Electrocardiogram (ECG) without clinically significant abnormalities;
- Intact oral mucosa before initiation of radiotherapy. Absence of active oral infections or severe periodontal disease before initiation of radiotherapy;
- Signed informed consent form.
Who cannot join
- Previous radiotherapy to the head and neck region;
- Head and neck surgery within the preceding 4 weeks;
- Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;
- Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);
- Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance <30 mL/min);
- Active systemic infection requiring antimicrobial therapy;
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- Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring ongoing immunosuppressive treatment;
- Severe psychiatric disorders that may impair the ability to provide informed consent or adhere to the study protocol;
- 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;
- Individuals unable to comprehend the study requirements or comply with study procedures;
- Any other condition that, in the judgment of the investigator, would render the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Rensheng Wang, 86+0771-5356509, 13807806008@163.com
About this study
Official title: Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis: A Randomized Controlled Trial
Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.
Read the detailed description
This study employs a randomized controlled design, aiming to enroll a total of 200 head and neck cancer patients scheduled to undergo radiotherapy from three medical centers. The experimental group (100 patients) will receive a mesenchymal stem cell-derived exosome spray, while the control group (100 patients) will follow a placebo-controlled design without any pharmacological intervention, receiving only standard radiotherapy and supportive care. The primary endpoint is the incidence of grade 3 or higher radiation-induced oral mucositis, which will be used to evaluate the efficacy of the investigational agent in preventing and ameliorating this condition through comparison with the control group.
- Being tested
- mesenchymal stem cell-derived exosomes
- Medical subject headings
- Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cell-derived exosomesDrug
Mesenchymal Exosome Administration Protocol: 1. Administration Timing: Begin 7 days prior to radiotherapy initiation and continue until 14 days post-radiotherapy completion. 2. Preparation: Remove the exosome vial, open the cap, add 5mL of saline solution, and secure the spray cap. 3. Administration Frequency: 3 times daily (30 minutes after breakfast, lunch, and dinner). 4. Dosage: Approximately 1.5mL per spray. 5. Administration Method: Oral spray. Evenly spray onto the oral mucosal surface. Avoid eating or rinsing for 20 minutes after administration.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | mesenchymal stem cell-derived exosomes. Administer the mesenchymal exosome spray three times daily-30 minutes after each main meal (breakfast, lunch, and dinner)-with a dosage of approximately 1.5 mL per application. Initiation of the study drug on the first day of radiotherapy and continuing through the completion of the treatment course. Receives: Drug: mesenchymal stem cell-derived exosomes |
| control group | No intervention | Patients in the control group received no drug interventions, only conventional radiotherapy and supportive care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade ≥3 radiation-induced oral mucositis
The primary endpoint is defined as the proportion of patients who develop grade 3 or higher radiation-induced oral mucositis (RIOM) from the start of radiotherapy until 90 days after the completion of radiotherapy. RIOM was graded according to the WHO oral toxicity scale criteria: Grade 0: No changes in the oral mucosa; Grade 1: Erythema of the oral mucosa with mild pain, not requiring analgesics; Grade 2: Patchy mucositis with serous exudate, moderate pain, usually not requiring analgesics; Grade 3: Confluent mucositis with severe pain requiring analgesics; Grade 4: Ulceration, hemorrhage, or necrosis, with intense pain affecting oral intake.
Measured: Within 90 days from the initiation to the completion of radiotherapy
Secondary outcomes (1)
Incidence rate of RIOM at any level
Assess the difference in the proportion of patients experiencing any grade (Grade 1 or higher) of RIOM between the intervention group and the control group to evaluate the overall preventive efficacy of the intervention.
Measured: Within 90 days from the initiation to the completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative) Due to RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The stratified block randomization method was employed to ensure balanced baseline characteristics between groups and the unpredictability of random allocation.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- LiuZhou People's Hospital, First People's Hospital of Yulin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312656
- Sponsor's protocol ID
- 2025-K0439
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07312656
- Acronym / sponsor ID
- 2025-K0439
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- LiuZhou People's Hospital, First People's Hospital of Yulin
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.
Detailed description
This study employs a randomized controlled design, aiming to enroll a total of 200 head and neck cancer patients scheduled to undergo radiotherapy from three medical centers. The experimental group (100 patients) will receive a mesenchymal stem cell-derived exosome spray, while the control group (100 patients) will follow a placebo-controlled design without any pharmacological intervention, receiving only standard radiotherapy and supportive care. The primary endpoint is the incidence of grade 3 or higher radiation-induced oral mucositis, which will be used to evaluate the efficacy of the investigational agent in preventing and ameliorating this condition through comparison with the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The stratified block randomization method was employed to ensure balanced baseline characteristics between groups and the unpredictability of random allocation.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: mesenchymal stem cell-derived exosomesmesenchymal stem cell-derived exosomes. Administer the mesenchymal exosome spray three times daily-30 minutes after each main meal (breakfast, lunch, and dinner)-with a dosage of approximately 1.5 mL per application. Initiation of the study drug on the first day of radiotherapy and continuing through the completion of the treatment course. |
| control group | No intervention | –Patients in the control group received no drug interventions, only conventional radiotherapy and supportive care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed malignant tumor of the head and neck;
- Age 18-75 years;
- Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and/or oropharynx;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months.
- White blood cell≥3.0×10^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10^9/ L
Key exclusion criteria (11 listed)
- Previous radiotherapy to the head and neck region;
- Head and neck surgery within the preceding 4 weeks;
- Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;
- Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);
- Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance <30 mL/min);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cell-derived exosomesMesenchymal Exosome Administration Protocol: 1. Administration Timing: Begin 7 days prior to radiotherapy initiation and continue until 14 days post-radiotherapy completion. 2. Preparation: Remove the exosome vial, open the cap, add 5mL of saline solution, and secure the spray cap. 3. Administration Frequency: 3 times daily (30 minutes after breakfast, lunch, and dinner). 4. Dosage: Approximately 1.5mL per spray. 5. Administration Method: Oral spray. Evenly spray onto the oral mucosal surface. Avoid eating or rinsing for 20 minutes after administration. | Drug | experimental group |
Primary outcome
The incidence of grade ≥3 radiation-induced oral mucositis
Time frame: Within 90 days from the initiation to the completion of radiotherapy
The primary endpoint is defined as the proportion of patients who develop grade 3 or higher radiation-induced oral mucositis (RIOM) from the start of radiotherapy until 90 days after the completion of radiotherapy. RIOM was graded according to the WHO oral toxicity scale criteria: Grade 0: No changes in the oral mucosa; Grade 1: Erythema of the oral mucosa with mild pain, not requiring analgesics; Grade 2: Patchy mucositis with serous exudate, moderate pain, usually not requiring analgesics; Grade 3: Confluent mucositis with severe pain requiring analgesics; Grade 4: Ulceration, hemorrhage, or necrosis, with intense pain affecting oral intake.
1 secondary outcome
Incidence rate of RIOM at any level
Time frame: Within 90 days from the initiation to the completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mesenchymal stem cell-derived exosomes in people with Oral Mucositis (Ulcerative) Due to Radiation, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rengsheng Wang, Ph.D (86+0771-5356509, 13807806008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade ≥3 radiation-induced oral mucositis (time frame: Within 90 days from the initiation to the completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.