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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy