Head and Neck CancerEarly Phase 1NCT06579248
Intraoral Hypothermia Device for Preserving Taste During Radiation
A Early Phase 1 study testing Intraoral Device in people with Head and Neck Cancer and Taste Dysfunction, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Taste Dysfunction, Radiation Therapy
- What is being tested?
- Intraoral Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 30 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being treated with combination radiation therapy and chemotherapy (definitive) for locally advanced (AJCC 8th cT3-4 or cN+) squamous cell carcinoma of the larynx.
- Age ≥ 18.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients will engage in the informed consent process and provide study-specific informed consent prior to study entry and must be able to fill out toxicity and quality of life related questionnaires.
- Patients should be concurrently treated with any of the following chemotherapy drugs: cisplatin, carboplatin, and cetuximab.
Who cannot join
- Patients receiving other forms of therapy intended to reduce taste dysfunction.
- Patients with metastatic disease.
- Patient with allergies or hypersensitivity to materials in the intraoral bolus.
- Patients who have received prior chemotherapy or radiation therapy for head and neck cancer.
- Patients who decline to use or cannot tolerate the intraoral device.
- Patients who are current or recent (within 3 months of treatment initiation) cigarette smokers.
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- Patients who are unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
- Patients with uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, immunocompromised state, significant hepatic insufficiency, significant hematological disease, and any serious or unstable psychological condition.
- Patients who are on any of the following medication that cannot find a suitable substitute during the study period: acetazolamide, maribavir (TAK-620, Phase 3 trial drug), eszopiclone, topiramate, captopril, lithium, procainamide, terbinafine, and amiodarone.
- Patients who have taste loss at baseline, assessed subjectively and objectively at the first encounter, will be excluded from the study and all analysis. They will be replaced with a new patient.
- Patients who have tested positive for COVID-19 during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202-2689
Marissa Gilbert, BSBME, 313-556-8422, mgilber6@hfhs.org
Farzan Siddiqui, MD PhD
About this study
Official title: Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx
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.
- Conditions
- Head and Neck Cancer, Taste Dysfunction, Radiation Therapy
- Being tested
- Intraoral Device
- Medical subject headings
- Head and Neck Neoplasms, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral DeviceDevice
Device that circulates cooled water through the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Hypothermia Device | Experimental | An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy. Receives: Device: Intraoral Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dysgeusia
Taste will be measured objectively using Burghart taste strips in five different concentrations of salty, sweet, sour, bitter, and umami. Taste will be assessed on a yes/no scale to reflect the ability to correctly identify taste category.
Taste will be measured subjectively with a series of previously-validated, patient-reported taste-related questions. The questions comprise of a modified Chemotherapy-induced Taste Alteration Scale (CiTAS), one question from the Head and Neck Quality of Life questionnaire (HNQOL, question 2H) and one question from the University of Washington Head and Neck-specific Quality of Life questionnaire (UWQOL, question 9).
The CiTAS uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste.
The HNQOL uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste.
The UWQOL uses a scale of 1-4, with 1 meaning taste is normal and 4 being unable to taste.
Questionnaires are used together to quantify change in taste.
Measured: 6 months after RT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start12 Nov 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farzan Siddiqui, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579248
- Sponsor's protocol ID
- 15529-01
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx
- ClinicalTrials.gov ID
- NCT06579248
- Acronym / sponsor ID
- 15529-01
- Conditions
- Head and Neck Cancer, Taste Dysfunction, Radiation Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoral Hypothermia Device | Experimental | Device: Intraoral DeviceAn intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients being treated with combination radiation therapy and chemotherapy (definitive) for locally advanced (AJCC 8th cT3-4 or cN+) squamous cell carcinoma of the larynx.
- Age ≥ 18.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients will engage in the informed consent process and provide study-specific informed consent prior to study entry and must be able to fill out toxicity and quality of life related questionnaires.
- Patients should be concurrently treated with any of the following chemotherapy drugs: cisplatin, carboplatin, and cetuximab.
Key exclusion criteria (11 listed)
- Patients receiving other forms of therapy intended to reduce taste dysfunction.
- Patients with metastatic disease.
- Patient with allergies or hypersensitivity to materials in the intraoral bolus.
- Patients who have received prior chemotherapy or radiation therapy for head and neck cancer.
- Patients who decline to use or cannot tolerate the intraoral device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral DeviceDevice that circulates cooled water through the oral cavity. | Device | Intraoral Hypothermia Device |
Primary outcome
Change in Dysgeusia
Time frame: 6 months after RT completion
Taste will be measured objectively using Burghart taste strips in five different concentrations of salty, sweet, sour, bitter, and umami. Taste will be assessed on a yes/no scale to reflect the ability to correctly identify taste category. Taste will be measured subjectively with a series of previously-validated, patient-reported taste-related questions. The questions comprise of a modified Chemotherapy-induced Taste Alteration Scale (CiTAS), one question from the Head and Neck Quality of Life questionnaire (HNQOL, question 2H) and one question from the University of Washington Head and Neck-specific Quality of Life questionnaire (UWQOL, question 9). The CiTAS uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste. The HNQOL uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste. The UWQOL uses a scale of 1-4, with 1 meaning taste is normal and 4 being unable to taste. Questionnaires are used together to quantify change in taste.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intraoral Device in people with Head and Neck Cancer and Taste Dysfunction, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marissa Gilbert, BSBME (313-556-8422, mgilber6@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dysgeusia (time frame: 6 months after RT completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.