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This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Patients in the control arm will receive the standard of care for RIOM. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine | Drug | Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of radiotherapy to 4 weeks after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of radiotherapy to 4 weeks after completion of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ma | Contact | +86-20-87343469 | yangkb@sysucc.org.cn | |
| Yu-Pei Chen, MD | Contact | +86-020-87343581 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Ma | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
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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.
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | From the start of radiotherapy to 4 weeks after completion of radiotherapy |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D014456 | Ulcer |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D013654 | Taurine |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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