Phase 3 Trial of Intraoral Cooling Device vs Ice Chips for Oral Mucositis Prevention

Overview

This randomized, blinded, multicenter phase 3 trial compared a novel intraoral cooling device (ICD) with conventional ice chips (IC) for preventing oral mucositis (OM) in patients undergoing high-dose chemotherapy and autologous stem cell transplantation. The study demonstrated that ICD is a feasible alternative to IC with potential benefits in tolerability and infection risk reduction.

Background

Oral mucositis affects up to 80% of patients receiving high-dose chemotherapy with hematopoietic stem cell transplantation, leading to significant morbidity including pain, infection risk, and treatment interruptions. Cryotherapy with ice chips has been used prophylactically to reduce OM by inducing vasoconstriction and lowering mucosal exposure to cytotoxic drugs. However, ice chips have limitations such as poor patient tolerability and potential microbial contamination. This trial evaluates a novel intraoral cooling device designed to overcome these limitations while maintaining efficacy.

Data Highlights

Key Findings

• OM incidence remains high in patients undergoing high-dose chemotherapy and ASCT, necessitating effective prophylaxis.
• IC induces vasoconstriction and reduces mucosal exposure to chemotherapy but has tolerability issues such as chills and dental pain.
• The ICD provides continuous intraoral cooling at a controlled temperature (8 °C) via a closed water circuit, potentially reducing microbial contamination risk.
• The trial was rigorously designed with randomization, blinding of outcome assessors, and standardized OM assessment using OMAS with excellent inter-rater reliability.
• Patients were instructed to use IC by moving ice around the mouth and rinsing melted slurry, while ICD was a single-use device with two sizes, connected to a thermostat unit.

Clinical Implications

The intraoral cooling device offers a promising alternative to ice chips for OM prevention, potentially improving patient comfort and reducing infection risks associated with waterborne pathogens in ice. Its controlled temperature and closed system design may enhance adherence and safety in immunocompromised patients undergoing high-dose chemotherapy and ASCT. Clinicians should consider device availability, patient preference, and institutional protocols when selecting cryoprevention methods.

Conclusion

This phase 3 trial establishes the feasibility and methodological rigor of comparing a novel intraoral cooling device with conventional ice chips for OM prevention. The ICD may represent an advancement in supportive care by addressing limitations of traditional cryotherapy.

References

1. Assessment of a new device for cryoprevention of oral mucositis: results from a randomized, blinded, multicenter, phase 3 trial