Actively Recruiting
ChemoRT With and Without Dental Stent for Taste Protection in NPC Patients
Led by National University Hospital, Singapore · Updated on 2024-12-13
50
Participants Needed
2
Research Sites
83 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
S
Singapore Institute of Food and Biotechnology Innovation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ChemoRT With and Without Dental Stent for Taste Protection in NPC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients newly diagnosed with histologically confirmed non-keratinizing nasopharyngeal carcinoma
- Tumors staged as T1-4N+ or TxN0-3
- No distant metastasis (M0)
- Karnofsky Performance Status of 70 or higher or ECOG less than 2
- Age 21 years or older
- Adequate bone marrow function with leucocytes ≥ 3 × 10⁹/L, neutrophils ≥ 1.5 × 10⁹/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 × 10⁹/L
- Normal liver function with ALT and AST under 1.5 times upper limit of normal, ALP under 2.5 times upper limit, and bilirubin within normal limits
- Creatinine clearance of 60 mL/min or higher
- Able to provide informed consent
- Induction chemotherapy before chemoradiation is allowed if no disease progression after chemotherapy
You will not qualify if you...
- Edentulous patients (missing all teeth)
- Extensive crown or implant dental work
- Diagnosis of basaloid squamous cell carcinoma or WHO keratinizing squamous cell carcinoma
- Previous malignancies except treated basal cell or squamous cell skin cancer and in-situ cervical cancer
- Previous radiation therapy except for non-melanomatous skin cancers outside treatment area
- Previous surgery or chemotherapy for primary tumors or lymph nodes, or history of glossectomy
- Prior diseases affecting saliva secretion or salivary gland function, abnormal taste, or eating disorders
- Current heavy smokers (more than 1 pack per day) or recent heavy smokers (stopped less than 2 years ago)
- Severe other diseases that pose risk or affect trial compliance like unstable cardiac disease, chronic hepatitis renal disease, poorly controlled diabetes, or emotional disturbances
- Pregnant or lactating women
- Inability to attend full course of radiation therapy or planned follow-up visits or surveys
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Singapore Institute of Food and Biotechnology Innovation
Singapore, Singapore, 117599
Not Yet Recruiting
2
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
Research Team
S
Shing Fung Lee, MBBS
CONTACT
F
Fatin Aliyah Binte Hussin, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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