Intraoral Cooling Device for Preserving Taste During Radiation Therapy

Overseen By Marissa Gilbert, BSBME

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Henry Ford Health System

Must be taking: Cisplatin, Carboplatin, Cetuximab

Must not be taking: Acetazolamide, Maribavir, Eszopiclone, others

Disqualifiers: Metastatic disease, Uncontrolled serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you find a substitute for certain medications if you are taking them. These include acetazolamide, maribavir, eszopiclone, topiramate, captopril, lithium, procainamide, terbinafine, and amiodarone. If you cannot find a suitable substitute, you may not be able to participate.

What data supports the effectiveness of the Intraoral Cooling Device treatment for preserving taste during radiation therapy?

Research on similar treatments, like oral cryotherapy, shows that cooling the mouth can help prevent oral mucositis (painful mouth sores) during chemotherapy by reducing tissue microcirculation. This suggests that cooling might also help preserve taste during radiation therapy by protecting oral tissues. ^{1 2 3 4 5}

Is the intraoral cooling device safe for use in humans?

Research on similar cooling devices in animals shows they are generally safe, with no significant side effects like tissue damage or discomfort observed during and after use. ^{3 6 7 8 9}

How does the intraoral cooling device treatment differ from other treatments for preserving taste during radiation therapy?

The intraoral cooling device is unique because it uses cooling to protect taste by reducing the temperature in the mouth, which is different from other treatments that may not focus on temperature control. This method is similar to oral cryotherapy used to prevent oral mucositis during chemotherapy, but it specifically targets taste preservation during radiation therapy. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with advanced larynx cancer, who are undergoing radiation and chemotherapy. They must be in good physical condition (ECOG status 0-1) and able to consent to the study as well as complete related questionnaires. Chemotherapy drugs used should include cisplatin, carboplatin, or cetuximab.

Inclusion Criteria

I am fully active or can carry out light work.

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

I am receiving radiation and chemotherapy for advanced larynx cancer.

Exclusion Criteria

Patient with allergies or hypersensitivity to materials in the intraoral bolus

I cannot or choose not to use the mouth device.

My cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy with the use of an intraoral hypothermia device to preserve taste function

6-8 weeks

Follow-up

Participants are monitored for changes in taste function using objective and subjective measures

6 months

Treatment Details

Interventions

• Intraoral Hypothermia Device

Trial Overview The study tests if an intraoral cooling device can prevent or reduce taste dysfunction during head and neck cancer treatments involving radiation therapy. It aims to determine the feasibility of using this device throughout treatment sessions.

Participant Groups

Group I: Intraoral Hypothermia Device Experimental Treatment 1 Intervention

An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Findings from Research

The new rectal cooling device for therapeutic hypothermia (TH) significantly reduced the time needed to induce cooling in rats with ischemic-hypoxic brain damage, achieving an induction time of about 37.3 minutes compared to 75.6 minutes with traditional ice blanket cooling.

The rectal TH cooling effectively decreased cell apoptosis in the brain and did not cause any histological damage to the rectal tissues, indicating its safety and efficacy as a treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a novel rectal cooling device in hypothermia therapy after cerebral hypoxia-ischemia in rats. Liu, P., Yang, R., Zuo, Z.[2018]

Oral cryotherapy is effective in preventing chemotherapy-induced oral mucositis, with the study showing that significant temperature drops in the oral mucosa occur within the first 5 minutes of cooling.

The study found that using ice chips resulted in a greater initial temperature reduction compared to an intraoral cooling device set at 15°C, suggesting that the method and temperature of cooling can influence the effectiveness of oral cryotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreventive temperatures prior to chemotherapy. Ibrahim, A., Camci, E., Khairallah, L., et al.[2023]

Induced hypothermia is increasingly recognized as a standard treatment for neuroprotection and cardioprotection, particularly in cases like postanoxic encephalopathy, based on growing clinical evidence.

The review highlights the importance of evaluating cooling devices, such as the Alsius CoolGard 3000, focusing on their effectiveness, potential side effects, and cost-effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equipment review: cooling catheters to induce therapeutic hypothermia? Polderman, KH., Callaghan, J.[2018]

Oral cryotherapy, using either ice chips or an intraoral cooling device, significantly alters oral microcirculation and tissue oxygen saturation, which may help prevent oral mucositis in cancer patients undergoing chemotherapy.

In a study with 10 healthy volunteers, the intraoral cooling device was preferred by 9 out of 10 participants over ice chips, suggesting it may be a more acceptable method for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamics of the oral mucosa during cooling: A crossover clinical trial. Walladbegi, J., Raber-Durlacher, JE., Jontell, M., et al.[2023]

The intra-oral air-cooling (IOAC) device effectively reduced oral mucosal temperature by 10.7°C after 5 minutes and 14.5°C after 60 minutes, demonstrating its potential as a preventive treatment for oral mucositis in cancer patients.

All 12 healthy volunteers tolerated the IOAC device for the full 60 minutes, although some reported minor adverse events like mouthpiece fit issues and hypersalivation, indicating that while effective, the device may need design improvements for better comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers. Blacker, C., Kamsvåg, T., Bejhed, RS., et al.[2021]

A novel esophageal device using high-flow dry air effectively induced therapeutic hypothermia in pigs, achieving a significant reduction in rectal temperature by 1°C within one hour, demonstrating its potential efficacy for neuroprotection.

The therapy was well-tolerated with no observed injuries to the oral or pharyngeal mucosa, and no acute or chronic complications were noted in the animals, indicating a promising safety profile for this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High-Flow Transesophageal Dry Air on Core Temperature: A Novel Method of Therapeutic Hypothermia. Assis, FR., Ambadipudi, S., Bhambhani, H., et al.[2021]

The NeuroSave device effectively lowered brain temperature by a median of 9°C within 60 minutes, demonstrating its potential for targeted cooling in neuroprotection after brain injuries, such as those from vascular events.

This novel device maintained systemic safety, with only a 2°C reduction in core body temperature and no adverse effects observed in a preclinical trial involving six adult pigs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Focal Therapeutic Hypothermia Device for Treatment of Acute Neurologic Injury: Large Animal Safety and Efficacy Trial. Carlstrom, LP., Perry, A., Graffeo, CS., et al.[2022]

The Cool Line catheter with Cool Gard system effectively maintained target body temperatures below 37 degrees Celsius in neurologic intensive care patients, demonstrating a low fever burden of 4.0 degrees C hours per patient over an average of 152.4 hours.

The device was generally safe, with complication rates comparable to standard care in similar patients, and a mortality rate of 23.5%, which aligns with expected outcomes for severe intracranial conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a novel intravascular cooling device to control body temperature in neurologic intensive care patients: a prospective pilot study. Schmutzhard, E., Engelhardt, K., Beer, R., et al.[2019]

Mild hypothermia can protect tissues from damage during ischemic events, but effectively inducing and maintaining hypothermia in awake patients is challenging due to strong thermoregulatory responses like shivering.

Current research is focused on finding safe pharmacological methods to induce hypothermia without causing excessive sedation or serious side effects, with combinations like meperidine and buspirone showing promise in facilitating this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiology and clinical relevance of induced hypothermia. Doufas, AG., Sessler, DI.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Application of a novel rectal cooling device in hypothermia therapy after cerebral hypoxia-ischemia in rats. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Cryopreventive temperatures prior to chemotherapy. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Equipment review: cooling catheters to induce therapeutic hypothermia? [2018]

4. England pubmed.ncbi.nlm.nih.gov

Hemodynamics of the oral mucosa during cooling: A crossover clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of High-Flow Transesophageal Dry Air on Core Temperature: A Novel Method of Therapeutic Hypothermia. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Novel Focal Therapeutic Hypothermia Device for Treatment of Acute Neurologic Injury: Large Animal Safety and Efficacy Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a novel intravascular cooling device to control body temperature in neurologic intensive care patients: a prospective pilot study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Physiology and clinical relevance of induced hypothermia. [2018]