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

NCT06733948 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-13

No results posted yet for this 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

Conditions

  • Nasopharyngeal Carcinoma

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

Sponsors & Collaborators

  • Singapore Institute of Food and Biotechnology Innovation

    collaborator OTHER_GOV

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Timothy Cheo, MBBS · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06733948 on ClinicalTrials.gov