Similar effectiveness of fomukal and caphosol in oral mucositis treatment after allogeneic hematopoietic stem cell transplantation

Abstract

Oral mucositis occurs in 75% to 100% of allogeneic HSCT recipients can cause pain, facilitate infections, delay discharge, and threaten life. The aim of the study was to evaluate prophylaxis with the remineralizing mouthwash solution of supersaturated calcium phosphate rinse (SCPR) with Fomukal on measures of severity of mucositis and consequent interventions and complications, in comparison to Caphosol, already evaluated post-transplant. In this prospective, randomized, non-inferiority trial, 46 patients undergoing allogeneic HSCT were equally randomized to Fomukal or Caphosol, each administered four times daily from initiation of conditioning until the granulocyte count ≥0.2 G/L. Hematologist measured the daily 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 of complications were also assessed. Fomukal vs. Caphosol groups had the same all following indicators: median measures of WHO oral mucositis reduction (0 vs. 2; P = NS), length of disease course (0 vs. 6 days; P = NS), peak and mean 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 = 0.011 and 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. Both SCPR mouth rinses, Fomukal and Caphosol, were associated with similar effectiveness in reducing severity of oral mucositis.