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Caphosol^® versus State-of-the-Art Mouth Care in Patients with Allogeneic Stem Cell Transplantation: A Randomized Controlled Trial

Abstract

Anja Kroner*, Erik Aerts, Urs Schanz and Rebecca Spirig

Objective: Oral mucositis (OM) is a common side effect of allogeneic stem cell transplantation and can lead to infections with increased morbidity, mortality, higher costs and an impact on the quality of patients’ lives. We conducted a study on the stem cell transplantation ward of a Swiss university hospital which treats oral mucositis with state-of-the-art measures.

Method and participants: In a randomized controlled, non-blinded trial involving 72 patients with allogeneic stem cell transplantation, we investigated the effectiveness of the oral rinse Caphosol® versus filtered water, in terms of duration of OM (primary endpoint), manifestation of OM and occurrence of pain, dry mouth, swallowing problems and changes in perception of taste (secondary endpoints).

Results: Results show Caphosol® had no effect on the duration of OM, with no difference in pain, dryness of mouth, swallowing problems and changes in perception of taste between the two groups. Predictors which seem to be associated with longer duration of OM are myeloablative conditioning and female gender. The number of oral rinses per day and in total show no significant correlation to duration of OM.

Conclusion: Consequently, in the setting of allogeneic stem cell transplantation in a patient group with a high risk for severe OM, oral rinsing with Caphosol® is not more effective than filtered water.