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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cooling device used in the mouth during radiation therapy can help preserve the sense of taste for individuals undergoing treatment for advanced throat cancer. Radiation often harms taste buds, and the cooling device might protect them by reducing damage. The trial seeks participants receiving both radiation and specific chemotherapy drugs for throat cancer. Those currently experiencing taste loss or who smoke may not be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking discoveries.

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 prior data suggests that this intraoral cooling device is safe for preserving taste during radiation therapy?

Research has shown that devices used to cool the mouth are generally easy to use. Studies have found that these devices can effectively cool the mouth without causing discomfort. In one study, healthy volunteers reported that the device was safe and comfortable. Another study demonstrated that cooling the mouth for just five minutes can significantly lower its temperature, indicating quick effectiveness without major side effects.

Although this trial is in its early stages, the device's use in similar situations suggests safety for people. It has been tested in other cases to help prevent mouth problems during cancer treatments. Overall, the evidence so far suggests that the intraoral cooling device is a safe option for preserving taste during radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The intraoral hypothermia device is unique because it directly cools the mouth to help preserve taste during radiation therapy, which is a common treatment for head and neck cancers. Unlike standard care options like medications and dietary adjustments that aim to manage taste loss after it happens, this device works proactively by lowering the temperature of the oral cavity during therapy sessions. Researchers are excited because this approach could prevent taste loss from occurring in the first place, improving patients' quality of life without adding more drugs to their regimen.

What evidence suggests that this intraoral cooling device is effective for preserving taste during radiation therapy?

Research has shown that cooling the mouth might help reduce damage from radiation therapy. In this trial, participants will use an intraoral hypothermia device to cool the oral cavity during radiation therapy. Early studies with this cooling device suggest it could help preserve taste function during treatment. Patients found this device more comfortable than ice chips, and both methods effectively lowered mouth temperature. Although more research is needed, these findings offer hope for people receiving radiation therapy to the head and neck. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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 fully active or can carry out light work.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/intraoral-cooling-device-for-preserving-taste-during-radiation-therapy-06a17

Intraoral Cooling Device for Preserving Taste During ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985184/

Feasibility and patient reported tolerance of cryotherapy ... Cryotherapy shows promising in alleviating symptoms of oral mucositis. Feasibility and tolerability of a cooling device in radiation therapy was ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06579248/intraoral-hypothermia-device-for-preserving-taste-during-radiation

Intraoral Hypothermia Device for Preserving Taste During ... Preliminary studies showed that cooling normal structures may lower damage caused by radiation. The purpose of this research study is to see if ...

4. link.springer.com link.springer.com/article/10.1007/s00280-017-3434-2

Innovative intraoral cooling device better tolerated and ... The intra-oral cooling device was significantly better tolerated than the ice-chips (p = 0.0118). The two interventions were equally effective regarding ...

5. researchgate.net researchgate.net/publication/390269485_Feasibility_and_patient_reported_tolerance_of_cryotherapy_with_Cooral_mouth_cooling_device_in_patients_undergoing_radiation_therapy_CooRay_a_pilot_study

Feasibility and patient reported tolerance of cryotherapy ... Overall, 214 CyT sessions were performed (73% of planned CyT sessions). The mean daily CyT duration was 48 minutes (range, 30–60 minutes). All ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10104916/

Cryopreventive temperatures prior to chemotherapy - PMC The greatest drop in intraoral temperature was seen after 5 min of cooling. This was true for all the tested cooling methods, i.e., IC, ICD8°C ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04915599

Feasibility and Patient Reported Tolerance of Cryotherapy ... This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in ...

8. nature.com nature.com/articles/s41409-021-01512-6

Efficacy of a novel device for cryoprevention of oral mucositis To our knowledge, this is the first randomized clinical trial comparing conventional ice therapy with an intraoral cooling device (ICD).

9. link.springer.com link.springer.com/article/10.1007/s12032-022-01932-4

Randomized cross-over study investigating the tolerability ... Conclusion. We found that oral cooling using a new IOAC device was tolerated and seems to be safe in healthy volunteers. Further studies are ...