Journal Article

Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations—a feasibility study and randomized controlled trial

Kamsvåg, Tove, Ljungman, Gustaf, von Essen, Louise, Winiarski, Jacek, Legert, Karin Garming, Arvidson, Johan, Mellgren, Karin, Svanberg, Anncarin, Toporski, Jacek

2020

Overview

Purpose To 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) . Methods Fifty-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. Results Forty-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. Conclusion The 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 registration ClinicalTrials.gov id: NCT01789658

• Publisher: Springer Berlin Heidelberg,Springer Nature B.V
• Subject: Adolescent / cancer / Cancer and Oncology / Cancer och onkologi / Chemotherapy / Child / Child, Preschool / Children / Clinical Medicine / Clinical trials / Compliance / Conditioning / content validity / Criteria / Critical incidents / Cryotherapy / Cryotherapy - methods / Discomfort / evaluation scale chimes / Feasibility / Feasibility Studies / Female / guidelines / Health Care Sciences & Services / Hematopoietic stem cell transplantation / Hematopoietic Stem Cell Transplantation - adverse effects / Hematopoietic Stem Cell Transplantation - methods / Humans / Incidence / Klinisk medicin / Male / management / Measures / Medical and Health Sciences / Medical records / Medicin och hälsovetenskap / Medicine / Medicine & Public Health / Mucositis / Narcotics / Nursing / Nursing Research / Oncology / Onkologi / Opioids / Oral / Oral cryotherapy / Oral mucositis / Original / Original Article / Pain / Pain - etiology / Pain - prevention & control / Pain Medicine / Patients / Pediatrics / Pediatrik / perspectives / prophylaxis / Registration / Rehabilitation / Rehabilitation Medicine / Severity / Stem cell transplantation / Stem cells / Stomatitis - etiology / Stomatitis - prevention & control / therapy / Transplantation Conditioning - adverse effects / Transplantation Conditioning - methods / Transplants / understandability