Nasopharyngeal Carcinoma (NPC), Oral Mucositis (Ulcerative) Due to Radiation
Conditions
Keywords
Radiation-induced Oral Mucositis, Nasopharyngeal Carcinoma, Taurine
Brief 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.
Interventions
DRUGTaurine
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years. 2. Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification). 3. Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system. 4. Scheduled to receive radical intensity-modulated radiotherapy (IMRT). 5. No prior history of anti-cancer treatment. 6. 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. 7. For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal. 8. Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.
Exclusion criteria
1. Known intolerance or hypersensitivity to taurine or its excipients. 2. Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction). 3. Prior history of malignant tumor. 4. Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.) 5. History or presence of severe oral ulcers, oral diseases, or salivary gland diseases. 6. Unwilling to stop smoking, drinking alcohol, or chewing betel nut. 7. Presence of severe active comorbidities. 8. Severe dysfunction of heart, brain, lung, or other vital organs. 9. Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders. 10. Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors. 11. Any other condition deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Radiation-Induced Oral Mucositis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset Time of Severe Radiation-Induced Oral Mucositis | From the start of radiotherapy to 4 weeks after completion of radiotherapy | 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. |
| Duration of Severe Radiation-Induced Oral Mucositis | From the start of radiotherapy to 4 weeks after completion of radiotherapy. | 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. |
| Recovery Rate of Severe Radiation-Induced Oral Mucositis | From the start of radiotherapy to 4 weeks after completion of radiotherapy | 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. |
| Incidence of Radiation-Induced Oral Mucositis | From the start of radiotherapy to 4 weeks after completion of radiotherapy | 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. |
| Incidence of Radiotherapy Interruption | From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks. | 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. |
| Quality of life (QoL) | From the start of radiotherapy to 4 weeks after completion of radiotherapy | 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. |
| Numeric Rating Scale for Pain | From the start of radiotherapy to 4 weeks after completion of radiotherapy | 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. |
| Safety as Assessed by CTCAE | From the start of radiotherapy to 4 weeks after completion of radiotherapy | Adverse events were monitored and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 |
Countries
China
Contacts
CONTACTJun Ma
CONTACTYu-Pei Chen, MD
PRINCIPAL_INVESTIGATORJun Ma
Sun Yat-sen University
Outcome results
None listed