Chemoradiotherapy With and Without Dental Stent for Taste Protection in Patients With Nasopharyngeal Carcinoma: a Randomized Controlled Trial
Primary objective: Evaluate and compare incidence of acute and long-term taste dysfunction in chemoradiation plus dental stent group vs. chemoradiation group, using objective-measured taste strip test, and patient-reported taste ability and toxicity. Secondary objectives: 1. Evaluate and compare incidence of acute and long-term toxicities (excluding taste) and patient-reported quality of life between chemoradiation plus dental stent group and chemoradiation group. 2. Evaluate and compare tumor response, overall survival, and failure-free survival between chemoradiation plus dental stent group and chemoradiation group. 3. Analyze dosimetric parameters of taste bud bearing tongue mucosa, ipsilateral/ contralateral parotid and submandibular glands extracted from RT plans and correlate with taste impair
• Patients newly diagnosed with histologically confirmed non-keratinizing NPC.
• Patients with Tumours staged as T1-4N+/TxN0-3.
• No sign of distant metastasis (M0).
• Satisfactory performance status (i.e., Karnofsky Performance Status ≥ 70 or ECOG \< 2)
• Age 21 years or older.
• Adequate bone marrow function by peripheral blood counts as demonstrated by the following laboratory values:
‣ ≥ 3 × 109/L leucocytes
⁃ ≥ 1.5 × 109/L neutrophils
⁃ ≥ 9 g/dL of haemoglobin, and
⁃ ≥ 100 × 109/L platelets.
• Normal liver function demonstrated by the following laboratory values:
‣ Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) concentrations of \< 1.5x upper limit of normal (ULN)
⁃ Alkaline phosphatase (ALP) concentration \< 2.5x ULN
⁃ Bilirubin \< ULN.
• Renal function: Creatinine clearance at ≥60 mL/min
• Able to provide informed consent
∙ 7\. Induction chemotherapy before radical chemoradiation to nasopharynx and neck is permissible if no disease progression after induction chemotherapy