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New treatment option for Head and Neck Cancer
Official title Intraoral Hypothermia Device for Preserving Taste During Radiation
ClinicalTrials.gov ID: NCT06579248
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients being treated with combination radiation therapy and chemotherapy (definitive) for locally advanced (AJCC 8th cT3-4 or cN+) squamous cell...
- 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...
- Patients should be concurrently treated with any of the following chemotherapy drugs: cisplatin, carboplatin, and cetuximab.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.