LBA37 - A blinded, randomized, parallel group, comparative investigation of a novel device (Cooral) for cryoprevention of oral mucositis

Background

Cryoprevention using ice chips (IC) have effectively been used to alleviate the onset and duration of chemotherapy-induced oral mucositis (OM). However, the use of IC may entail adverse reactions e.g., chills, nausea and shooting pain in the teeth, which will influence the tolerability and, thus, compliance. In addition, IC requires water of good quality to minimize risk of serious infections in already immunocompromised patients. To eliminate these adverse incidents, this study was conducted to evaluate the efficacy of a novel intraoral cooling device (ICD) for cryoprevention of OM.

Methods

In total 182 patients with multiple myeloma or lymphoma, scheduled to receive high-dose chemotherapy prior to hematopoietic stem cell transplantation, were included and randomly assigned (1:1) to cooling with IC or the ICD. Each cooling session started 30 minutes prior to the chemotherapy infusion and continued for 30 minutes after the infusion was completed. Patients were followed up for up to 28 days and OM was assessed employing the Oral Mucositis Assessment Scale (OMAS). The primary endpoint, peak OMAS, was analyzed by a multiple linear regression model with fixed explanatory variables, treatment group and type of cancer.

Results

When the entire patient material was analyzed for OMAS-total, the two cooling methods were equally effective, and severe OM was found to be below 10%. However, when the lymphoma group was analyzed separately, the ICD significantly reduced the OMAS-total score to a greater extent compared to IC (mean = 1.77 vs 3.08; p=0.047). Both diagnostic groups reported a higher degree of tolerability when ICD was compared with IC (OR=0.245; p<0.02).

Conclusions

Cryoprevention is an effective strategy to prevent chemotherapy-induced oral mucositis. The conventional cooling method of using ice was shown to be further improved by the use of the intraoral device both regarding the prevention of oral mucositis for specific diagnostic groups as well as for the reported tolerability.

Clinical trial identification

NCT03203733.

Editorial acknowledgement

Legal entity responsible for the study

Braincool AB.

Funding

Braincool AB.

Disclosure

J. Walladbegi: Honoraria (self), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: BrainCool AB. A. Svanberg: Advisory/Consultancy: BrainCool AB. M. Jontell: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options: BrainCool AB. R.K. Henriksson: Shareholder/Stockholder/Stock options, Officer/Board of Directors: BrainCool AB; Advisory/Consultancy: Alivia. F. Schjesvold: Advisory/Consultancy, Shareholder/Stockholder/Stock options: Oncopeptides; Honoraria (self): SkyliteDX; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Celgene; Honoraria (self): Takeda; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Novartis Pharma SAS; Research grant/Funding (institution): Braincool; Advisory/Consultancy: Sanofi . G. Larfors: Research grant/Funding (institution): BrainCool AB. M. Jädersten: Research grant/Funding (institution): BrainCool AB. All other authors have declared no conflicts of interest.