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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National University Hospital
  Singapore, Singapore Recruiting
• Singapore Institute of Food and Biotechnology Innovation
  Singapore, Singapore Not yet recruiting

Study contacts

• Principal investigator: Timothy Cheo, MBBS — National University Hospital, Singapore
• Study coordinator: Shing Fung Lee, MBBS
• Email: leesf@nuhs.edu.sg
• Phone: +6567726392

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.