Dental stent: Dental stent is personalised device for tongue depressing and immobilisation during RT. The aims are to reduce unnecessary RT doses to adjacent non-target healthy tissue, including the tongue, adjacent oral mucosa, parotid glands/ submandibular glands, and temporomandibular joints. Dentists will take impression of the teeth on moulds, and measure the height to raise the bite, the stent is then fabricated as methyl methacrylate resin in the dental laboratory. The resin base extends to the tongue and a flat plate depresses the tongue. This device will be placed before each RT fraction.
No dental stent: No dental stent used during chemoradiation treatment
Study summary
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
Eligibility
Sex
ALL
Min age
21 Years
Max age
100 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Patient-assessed taste impairment using the QLQ-HN43 module — From baseline to 52 weeks post-RT Patient-assessed taste impairment measured on 4-point verbal rating scale, ranging from none to severe using the QLQ-HN43 module.
Taste impairment assessed on NCI CTCAE version 5.0 grading — From baseline to 52 weeks post RT Taste alterations (dysgeusia) will be graded between Grades 0 to 2.
Taste impairment measured on the STTA scale — From baseline to 52 weeks post-RT The STTA scale modified from the Late Effects Normal Tissue/Subjective Objective Management Analytic is a scoring system for taste acuity ranging from Grades 0 to 4
Objective testing using test strips — From baseline to 52 weeks post-RT Taste strips are a validated approach to assess taste ability for the five primary taste modalities - sweet, sour, salty, bitter, and umami.
Trial sites (2)
Facility
City
Region
Status
Singapore Institute of Food and Biotechnology Innovation
Singapore
Singapore
Not Yet Recruiting
National University Hospital
Singapore
Singapore
Recruiting
More National University Hospital, Singapore trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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