Oral Mucositis (Ulcerative) Due to RadiationPhase 2NCT07567742
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
A Phase 2 study testing Taurine in people with Oral Mucositis (Ulcerative) Due to Radiation and Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Taurine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 30 Mar 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years.
- Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).
- Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.
- Scheduled to receive radical intensity-modulated radiotherapy (IMRT).
- No prior history of anti-cancer treatment.
- ECOG performance status 0-1; adequate organ function within 2 weeks before enrollment; Hematology: hemoglobin > 90 g/L; absolute neutrophil count > 1.5×10⁹/L; platelet count > 100×10⁹/L. Biochemistry: total bilirubin ≤ 1.5×ULN; ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; creatinine clearance ≥ 50 mL/min.
- For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.
- Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.
Who cannot join
- Known intolerance or hypersensitivity to taurine or its excipients.
- Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Prior history of malignant tumor.
- Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)
- History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.
- Unwilling to stop smoking, drinking alcohol, or chewing betel nut.
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- Presence of severe active comorbidities.
- Severe dysfunction of heart, brain, lung, or other vital organs.
- Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.
- Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.
- Any other condition deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu-Pei Chen, MD contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Jun Ma, +862087343469, majun2@mail.sysu.edu.cn
Jun Ma
About this study
Official title: Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
- Being tested
- Taurine
- Keywords
- Radiation-induced Oral Mucositis, Nasopharyngeal Carcinoma, Taurine
- Medical subject headings
- Stomatitis, Ulcer, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurineDrug
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Taurine | Experimental | Oral taurine 1 g twice daily, starting 3 days before radiotherapy until 1 week after completion of radiotherapy, plus standard of care for RIOM. Receives: Drug: Taurine |
| Control | No intervention | Patients in the control arm will receive the standard of care for RIOM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Radiation-Induced Oral Mucositis
The incidence of Grade ≥3 radiation-induced oral mucositis (RIOM) in the experimental and control groups, as assessed using the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Secondary outcomes (8)
Onset Time of Severe Radiation-Induced Oral Mucositis
The interval from the start of radiotherapy to the first occurrence of severe radiation-induced oral mucositis (RIOM). Severe RIOM is defined as Grade ≥3 according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Duration of Severe Radiation-Induced Oral Mucositis
The interval from the first occurrence of severe acute radiation-induced oral mucositis (RIOM) to its resolution to Grade ≤2, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale. Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Recovery Rate of Severe Radiation-Induced Oral Mucositis
The proportion of patients whose severe acute radiation-induced oral mucositis (RIOM) resolves to Grade ≤2 during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale. Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Incidence of Radiation-Induced Oral Mucositis
The proportion of patients who develop any-grade acute radiation-induced oral mucositis (RIOM) (Grade ≥1) during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Incidence of Radiotherapy Interruption
The proportion of patients who experience a radiotherapy interruption of 5 or more consecutive days during the radiotherapy period due to acute radiation-induced oral mucositis (RIOM) or other related adverse events.
Measured: From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
Quality of life (QoL)
Quality of life related to head and neck symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Module (EORTC QLQ-H\&N35), version 1.0. This questionnaire comprises 35 items, including seven multi-item scales and 11 single-item measures. All scales and items will be scored according to the official EORTC Scoring Manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater symptom burden and poorer quality of life.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Numeric Rating Scale for Pain
Oral mucositis-related pain was assessed in all participants using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Safety as Assessed by CTCAE
Adverse events were monitored and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: From the start of radiotherapy to 4 weeks after 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 posted5 May 2026
- Study start8 May 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2029 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, open-label, randomized controlled Phase 2 clinical trial investigating taurine for the prophylaxis and treatment of radiation-induced oral mucositis in patients with nasopharyngeal carcinoma. Eligible participants will be randomized in a 1:1 ratio to receive taurine plus standard of care or standard of care alone.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, MD, Sun Yat-sen University
- Investigators
- Jun Ma, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567742
- Sponsor's protocol ID
- 2026-FXY-049-FLK
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT07567742
- Acronym / sponsor ID
- 2026-FXY-049-FLK
- Keywords
- Radiation-induced Oral Mucositis, Nasopharyngeal Carcinoma, Taurine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 5 May 2026 (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.
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, open-label, randomized controlled Phase 2 clinical trial investigating taurine for the prophylaxis and treatment of radiation-induced oral mucositis in patients with nasopharyngeal carcinoma. Eligible participants will be randomized in a 1:1 ratio to receive taurine plus standard of care or standard of care alone.
| Arm | Type | Receives |
|---|---|---|
| Taurine | Experimental | Drug: TaurineOral taurine 1 g twice daily, starting 3 days before radiotherapy until 1 week after completion of radiotherapy, plus standard of care for RIOM. |
| Control | No intervention | –Patients in the control arm will receive the standard of care for RIOM. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-70 years.
- Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).
- Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.
- Scheduled to receive radical intensity-modulated radiotherapy (IMRT).
- No prior history of anti-cancer treatment.
Key exclusion criteria (11 listed)
- Known intolerance or hypersensitivity to taurine or its excipients.
- Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Prior history of malignant tumor.
- Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)
- History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.
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 |
|---|---|---|
| TaurineOral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy. | Drug | Taurine |
Primary outcome
Incidence of Severe Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
The incidence of Grade ≥3 radiation-induced oral mucositis (RIOM) in the experimental and control groups, as assessed using the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
8 secondary outcomes
Onset Time of Severe Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Duration of Severe Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Recovery Rate of Severe Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Incidence of Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Incidence of Radiotherapy Interruption
Time frame: From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
Quality of life (QoL)
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Numeric Rating Scale for Pain
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Safety as Assessed by CTCAE
Time frame: From the start of radiotherapy to 4 weeks after 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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yu-Pei Chen, MD contact
Jun Ma principal investigator
Sun Yat-sen University
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 Taurine in people with Oral Mucositis (Ulcerative) Due to Radiation and Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen 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 8 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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 Jun Ma (+86-20-87343469, yangkb@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Radiation-Induced Oral Mucositis (time frame: From the start of radiotherapy to 4 weeks after 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 30 Oct 2026.