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RECRUITING
NCT06733948
PHASE2

ChemoRT With and Without Dental Stent for Taste Protection in NPC Patients

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

21 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-09-24

Completion Date

2026-05

Last Updated

2024-12-13

Healthy Volunteers

No

Interventions

DEVICE

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.

OTHER

No dental stent

No dental stent used during chemoradiation treatment

Locations (2)

Singapore Institute of Food and Biotechnology Innovation

Singapore, Singapore

National University Hospital

Singapore, Singapore