Abstract
PurposeTo evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC reduces the incidence of severe oral mucositis (OM), oral pain, and opioid use in children undergoing hematopoietic stem cell transplantation (HSCT).MethodsFifty-three children, 4–17 years old, scheduled for HSCT in Sweden were included and randomized to OC or control using a computer-generated list. OC instructions were to cool the mouth with ice for as long as possible during chemotherapy infusions with an intended time of ≥ 30 min. Feasibility criteria in the OC group were as follows: (1) compliance ≥ 70%; (2) considerable discomfort during OC < 20%; (3) no serious adverse events; and (4) ice administered to all children. Grade of OM and oral pain was recorded daily using the WHO-Oral Toxicity Scale (WHO-OTS), Children’s International Oral Mucositis Evaluation Scale, and Numerical Rating Scale. Use of opioids was collected from the medical records.ResultsForty-nine children (mean age 10.5 years) were included in analysis (OC = 26, control = 23). The feasibility criteria were not met. Compliance was poor, especially for the younger children, and only 15 children (58%) used OC as instructed. Severe OM (WHO-OTS ≥ 3) was recorded in 26 children (OC = 15, control = 11). OC did not reduce the incidence of severe OM, oral pain, or opioid use.ConclusionThe feasibility criteria were not met, and the RCT could not show that OC reduces the incidence of severe OM, oral pain, or opioid use in pediatric patients treated with a variety of conditioning regimens for HSCT.Trial registrationClinicalTrials.gov id: NCT01789658
Highlights
Oral mucositis (OM) is a common adverse effect of antineoplastic treatment [1, 2]
The primary objectives of this study are to evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC decreases the grade of OM, oral pain, and use of opioids in children undergoing hematopoietic stem cell transplantation (HSCT)
Two children declined participation after randomization to the control group and used oral cryotherapy at will, one child was admitted to the intensive care unit, and one child was cared for at home within the first days after transplant resulting in lack of data and was removed from the analyses
Summary
Oral mucositis (OM) is a common adverse effect of antineoplastic treatment [1, 2]. The condition often causes pain and difficulties in basal functions, such as talking and swallowing, which in turn affect drinking and eating. OM is reported to be one of the most painful and debilitating side effects of cancer treatment in pediatric patients [3,4,5]. The incidence of OM in children ranges between 52 and 81% depending on the type of antineoplastic treatment given [6, 7]. OM delays treatment, which reduces its intensity and increases the incidence of infections, total parental nutrition use, drug consumption, and hospitalization [1]. As well as causing an increased morbidity and suffering, OM increases healthcare costs and mortality [8]
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