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.
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.
