Clinical trial · Interventional
ChemoRT With and Without Dental Stent for Taste Protection in NPC Patients
Chemoradiotherapy With and Without Dental Stent for Taste Protection in Patients With Nasopharyngeal Carcinoma: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dental stent | Device | — | UNRESOLVED |
| No dental stent | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Radiotherapy with dental stent +/- Concurrent systemic therapy
- interventionNames
- Device: Dental stent
- type
- OTHER
- label
- Control
- description
- Radiotherapy with no dental stent +/- Concurrent systemic therapy
- interventionNames
- Other: No dental stent
Primary outcomes (4)
- measure
- Patient-assessed taste impairment using the QLQ-HN43 module
- timeFrame
- From baseline to 52 weeks post-RT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC. 2. Patients with Tumours staged as T1-4N+/TxN0-3. 3. No sign of distant metastasis (M0). 4. Satisfactory performance status (i.e., Karnofsky Performance Status ≥ 70 or ECOG \< 2) 5. Age 21 years or older. 6. Adequate bone marrow function by peripheral blood counts as demonstrated by the following laboratory values: 1. ≥ 3 × 109/L leucocytes 2. ≥ 1.5 × 109/L neutrophils 3. ≥ 9 g/dL of haemoglobin, and 4. ≥ 100 × 109/L platelets. 7. Normal liver function demonstrated by the following laboratory values: 1. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) concentrations of \< 1.5x upper limit of normal (ULN) 2. Alkaline phosphatase (ALP) concentration \< 2.5x ULN 3. Bilirubin \< ULN. 8. Renal function: Creatinine clearance at ≥60 mL/min 9. Able to provide informed consent 7\. Induction chemotherapy before radical chemoradiation to nasopharynx and neck is permissible if no disease progression after induction chemotherapy Exclusion Criteria: 1. Edentulous patients 2. Extensive crown/ implant work to the teeth 3. Patients having basaloid squamous cell carcinoma or WHO keratinizing squamous cell carcinoma. 4. Patients who suffered from previous malignancies, except adequately treated basal cell or squamous cell skin cancer, and in-situ cervical cancer. 5. Received RT previously (except for non-melanomatous skin cancers outside the intended RT treatment area) 6. Patients who received previous surgery (except diagnostic) or chemotherapy for the primary tumours or lymph nodes or history of glossectomy. 7. Patient who had a prior diagnosis of diseases effecting saliva secretion or causing salivary glands impairment (i.e., Sjogren's syndrome, iodine cancer treatment), had a reported history of abnormal sense of taste or eating disorders. 8. Current heavy smokers (smoke \> 1 pack/day) or previous heavy smokers (stopped smoking less than 2 years and had smoked \> 1 pack/day). 9. Patients suffering from any severe intercurrent disease, which may incur unacceptable risk or negatively affect trial compliance. For example, unstable cardiac disease necessitating treatment, chronic hepatitis renal disease, poorly controlled diabetes (fasting plasma glucose greater 1.5x upper limit of normal), and emotional disturbance. 10. Pregnant or lactating women. 11. Inability to attend the full course of RT or planned follow-up/survey responses.
References
Publications (0)
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