Clinical Data Supporting the Chemo Mouthpiece
Oral mucositis is a debilitating and clinically significant side effect of many chemotherapy treatments. Clinical utility of the Chemo Mouthpiece is supported by a growing body of peer-reviewed evidence, including randomized controlled trials, subset analyses, case series, and health economic modeling.
- 46% decrease in oral pain1
- 68% decrease in use and duration of opioid and non-opioid analgesics1
- Efficacy across a wide range of cancer types and chemotherapy regimens1
- Favorable patient-reported experience and tolerability1
- Favorable outcomes observed in patients with ADC-associated oral mucositis2
About the Chemo Mouthpiece®
Designed for use during chemotherapy treatment and at home following infusion, the Chemo Mouthpiece delivers consistent, uniform cooling across the oral cavity.
- 6 prefilled oral cooling devices and cooler
- Reusable throughout treatment—single patient, multi-use
- Designed for infusion and at-home use
- Patient-managed
How to Prescribe the Chemo Mouthpiece
1. Download the Referral Form
2. Submit the completed form to Zeal Specialty Pharmacy
3. Zeal supports: Benefits investigation, prior authorization, onboarding, Patient Assistance Program, and fulfillment
Designed for Real-World Oncology Care
- Studied in patients across more than 17 cancer types and 30 chemotherapy regimens1
- Designed for use before, during, and after infusion, with continued at-home use1
- Portable, patient-managed oral cooling that supports treatment beyond the infusion center
- No device-related safety concerns reported in the clinical trial1
- Supported by peer-reviewed evidence, including randomized clinical trials, health economic analyses, and published outcomes in ADC-associated oral mucositis1-3
The Chemo Mouthpiece cools the entire oral cavity evenly. Darker areas represent colder temperatures.
(Data on file)
Patient Access & Financial Assistance
Zeal Specialty Pharmacy supports oncology practices with prescribing coordination, benefits investigation, prior authorization support, patient onboarding, and Patient Assistance Program (PAP) services.
INDICATION (Rx Only):
The Chemo Mouthpiece® is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.
View full Instructions for Use and Prescriber Information.
IMPORTANT SAFETY INFORMATION:
Please see full Prescriber Information and Instructions for Use for complete warnings and precautions.
References: 1. Zuniga, R., Dembla, V., Alam, N. et al. Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device. Support Care Cancer 33, 732 (2025). 2. Fantozzi PJ, Sonis ST, Diaz JP, Villa A. Oral mucositis secondary to datopotamab deruxtecan for advanced-stage cancer managed with cryotherapy after topical steroid failure: A case series study. J Am Dent Assoc. 2026 Jan 28:S0002-8177(25)00693-2. doi: 10.1016/j.adaj.2025.11.015. Epub ahead of print. PMID: 41609549. 3. Zuniga R, Dineen A, Velasquez R, Lee DD, Zara A, Tattoli B, Bourque M, Jacobucci F. An economic analysis of Chemo Mouthpiece® versus supportive care for the reduction of oral mucositis incidence in patients receiving chemotherapy. J Comp Eff Res. 2026 Mar;15(3):e250164. doi: 10.57264/cer-2025-0164. Epub 2026 Feb 27. PMID: 41757395; PMCID: PMC12976640.