Using a dental stent to protect taste in nasopharyngeal cancer patients during treatment

Chemoradiotherapy With and Without Dental Stent for Taste Protection in Patients With Nasopharyngeal Carcinoma: a Randomized Controlled Trial

This study is testing if a special dental stent can help people with nasopharyngeal cancer keep their sense of taste while they undergo chemotherapy and radiation treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 21 Years to 100 Years
• Sex: All
• Sponsor: National University Hospital, Singapore (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Singapore and 1 other locations)
• Trial ID: NCT06733948 on ClinicalTrials.gov

What this trial studies

This phase II randomized control trial aims to evaluate the effectiveness of a dental stent in preserving taste sensation in patients with nasopharyngeal carcinoma undergoing chemoradiation. Participants will be randomly assigned to receive either standard chemoradiation or chemoradiation with a personalized dental stent. The study will assess both acute and long-term taste dysfunction through objective taste tests and patient-reported outcomes. Additionally, it will evaluate other toxicities, quality of life, tumor response, and survival rates over a follow-up period of up to 52 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma without distant metastasis.

Not a fit: Patients with distant metastasis or those with significant comorbidities affecting treatment tolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for nasopharyngeal cancer patients by preserving their taste sensation during treatment.

How similar studies have performed: While the use of dental stents in this context is relatively novel, similar studies exploring taste preservation during cancer treatments have shown promising results.

Eligibility criteria

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.

Where this trial is running

Singapore and 1 other locations

• Singapore Institute of Food and Biotechnology Innovation — Singapore, Singapore (Not_yet_recruiting)
• National University Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Timothy Cheo, MBBS — National University Hospital, Singapore
• Study coordinator: Shing Fung Lee, MBBS

Conditions Nasopharyngeal Carcinoma; nasopharyngeal cancer; dental stent; nasopharyngeal carcinoma; chemogustrometry; taste test; chemoradiation