NCT06733948

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a phase II randomized control trial assessing the efficacy of adding a dental stent for sparing the taste bud and protect the taste sensation in NPC patients undergoing chemoradiation. The enrolled participants will be randomized to add a personalized dental stent during the radical chemoradiation to nasopharynx and neck using IMRT technique. Chemoradiation must begin no later than 4 weeks from the time of recruitment, although treatment as early as possible is highly encouraged. A total of 50 patients (25 patients each arm) will be accrued to assess the potential benefit and safety of the said dental stent to standard chemoradiation. All participants will be followed up as follows: 1. One visit before induction chemotherapy (if any) 2. One visit within 6 weeks before RT 3. Weekly during treatment and at the end of treatment (6-7 visits depending on treatment schedule), 4. One visit at 4 weeks post treatment (with +/-2 weeks window period) 5. One visit at 12 weeks post treatment (with +/- 4 weeks window period) 6. One visit at 26 weeks post treatment (with +/-4 weeks window period) and 7. One visit at 52 weeks post treatment (with +/-4 weeks window period) to review their general condition, toxicities, and long-term treatment efficacy and safety profile. The assessment of taste sensation using subjective questionnaires, alongside objective measures using taste strip tests are performed at baseline, the 12 weeks post treatment follow up and at the 52 weeks post treatment follow up visits.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-24
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2024-12-13
• Last updated: 2024-12-13

Locations

2 sites across 1 country: Singapore