RecruitingEarly Phase 1NCT06579248

Intraoral Hypothermia Device for Preserving Taste During Radiation

Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx


Sponsor

Henry Ford Health System

Enrollment

15 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Radiation therapy to the head and neck region is known to cause taste dysfunction. Preliminary studies showed that cooling normal structures may lower damage caused by radiation. The purpose of this research study is to see if it is feasible to use an intraoral cooling device during radiation treatments to preserve or lower the decline of taste function.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device worn in the mouth during radiation therapy for throat/larynx cancer to cool the taste glands and try to preserve the sense of taste, which is often damaged by radiation treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with locally advanced squamous cell carcinoma of the larynx (throat cancer) - You are receiving combined radiation and chemotherapy (definitive chemoradiation) as treatment - You are in good physical condition (ECOG 0–1) - You are able to complete questionnaires about taste and quality of life **You may NOT be eligible if...** - You have had prior radiation therapy to the head or neck - You have certain dental or mouth conditions that prevent wearing the device - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntraoral Device

Device that circulates cooled water through the oral cavity.


Locations(1)

Henry Ford Health System

Detroit, Michigan, United States

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NCT06579248


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