Treister, N., Nieder, M., Baggott, C., Olson, E., Chen, L., Dang, H., . . . Sung, L. (2016). Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation. British Journal of Cancer, 116, 21–27.
To determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning, reduces the duration of severe oral mucositis (OM) compared with placebo among children and adolescents undergoing hematopoietic cell transplantation (HCT)
Supplied Caphosol A (phosphate solution) and B (calcium solution) or sterile 0.9% sodium chloride solution were provided by two unblinded pharmacists after patients were randomized 1:1 between treatment and control groups. The nurses mixed the Caphosol in the syringes to form a pH-neutral supersaturated solution. The children and adolescents rinsed their mouths thoroughly for one minute, gargled, and spit with one-half of the mixed solution. They repeated with the remaining solution for a total rinse time of two minutes. Younger children with small mouths could rinse with a reduced volume. Participants rinsed four times per day (two rinses per episode) at approximately evenly spaced intervals. The therapy was initiated on the first day of conditioning and continued daily until after day 20 or hospital discharge, whichever occurred first. The subjects were assessed daily for OM by trained study staff until refusal by patient to participation, day +2-, or discharge home. Common Terminology Criteria for Adverse Events (CTCAE) criteria were used to assess toxicity.
Phase III, international, multicenter, randomized, double-blinded, placebo-controlled, prospective clinical trial. The primary endpoint was the duration of severe OM (World Health Organization [WHO] score of 3 or greater).
The mean duration of severe OM was not reduced among Caphosol (4.5, SD = 5 days) versus placebo (4.5, SD = 4.8; p = 0.99) recipients. No significant differences existed in any of the secondary endpoints between the groups.
Caphosol did not reduce severe OM compared with placebo among children and adolescents undergoing myeloablative HCT.
Caphosol did not reduce severe OM compared with placebo among children and adolescents undergoing myeloablative HCT. Effective interventions for OM is needed in this and in other populations.