Similar effectiveness of Fomukal and Caphosol in oral mucositis treatment after allogeneic hematopoietic stem cell transplantation

Objective: Oral mucositis occurs in 75% to 100% of allogeneic HSCT recipients can cause pain, facilitateinfections, delay discharge, and threaten life. The aim of the study was to evaluate prophylaxiswith the remineralizing mouthwash solution of supersaturated calcium phosphate rinse(SCPR) with Fomukal on measures of severity of mucositis and consequent interventions andcomplications, in comparison to Caphosol, already evaluated post-transplant. Materials/Methods: In this prospective, randomized, non-inferiority trial, 46 patients undergoing allogeneic HSCTwere equally randomized to Fomukal or Caphosol, each administered four times daily frominitiation of conditioning until the granulocyte count ≥0.2 G/L. Hematologist measured thedaily severity of mucositis according to a WHO scale and patients self-assessed its symptoms.Need for analgesics, anti-infectious drugs, total parenteral nutrition (TPN) and incidence ofcomplications were also assessed.Results: Fomukal vs. Caphosol groups had the same all following indicators: median measures of WHOoral mucositis reduction (0 vs. 2; P = NS), length of disease course (0 vs. 6 days; P = NS), peak andmean mouth (1 vs. 2; P = NS and 0.06 vs. 1; P = NS) and throat pain (1 vs. 1; P = NS and 0.22 vs.0.31; P = NS), and peak and mean swallowing problems (1 vs. 1; P = NS and 0.19 vs. 0.25; P = NS).Analgesics need (7 vs. 10 patients; 0 vs. 0 days; P = NS) and the need for antifungals (1 vs. 2 drugs;P = NS) were not different, while the need for antibiotics and antivirals (3.5 vs. 5 drugs; P = 0.011and 1 vs. 2 drugs; P = 0.023) were lower in the Fomukal group. Measures of complications: infections(7 vs. 12 patients, P = NS) and a GVHD (13 vs. 14 patients, P = NS, grade 1 vs. 1, P = NS) did not differ.Discussion: Both SCPR mouth rinses, Fomukal and Caphosol, were associated with similar effectiveness inreducing severity of oral mucositis.