An open-label parallel-group study conducted at 12 sites across 4 countries investigated the safety and tolerability of episil®
oral liquid plus standard of care (SOC) versus SOC alone on severity and duration of oral mucositis symptoms in patients (n=116) receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). Patients scheduled for myeloablative or intense reduced-intensity conditioning treatment followed by HSCT (n=116) were randomized 1:1 to SOC (which included basic oral hygiene) or SOC plus episil®
treatment. Of the 109 patients (median age 50 years) who received study treatment (intention-to-treat [ITT] population), 23 were excluded from the per-protocol (PP) population because of inadequate compliance (<50% of study days with 100% compliance).
The major findings of the study:
- WHO Oral Toxicity Score, which reflects oral mucositis severity across the 28 days of treatment, was significantly lower for SOC plus episil® than for SOC alone in the PP population (adjusted mean 0.5 versus 0.7, p=0.028).
- There was a tendency of faster decrease of WHO scores in SOC + episil® group than in SOC group in the ITT population, and also lower average WHO scores in SOC + episil® group compared to SOC group in the PP population.