Intraoral Hypothermia Device for Preserving Taste During Radiation

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06579248
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraoral Device — DEVICE
    Device that circulates cooled water through the oral cavity.

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Jan 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Intraoral Hypothermia Device
    An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy.

Primary Outcome Measure

Change in Dysgeusia [ Time Frame: 6 months after RT completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202-2689
Marissa Gilbert, BSBME
[email protected]
313-556-8422
Farzan Siddiqui, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Detroit, MI

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Henry Ford Health System· Detroit, MI

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