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Open Access 01-10-2020 | Opioids | Original Article

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

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

Published in: Supportive Care in Cancer | Issue 10/2020

Abstract

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

Available only for authorised users

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Title: Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations—a feasibility study and randomized controlled trial
Authors: Tove Kamsvåg
Anncarin Svanberg
Karin Garming Legert
Johan Arvidson
Louise von Essen
Karin Mellgren
Jacek Toporski
Jacek Winiarski
Gustaf Ljungman
Publication date: 01-10-2020
Publisher: Springer Berlin Heidelberg
Keywords: Opioids
Opioids
Cryotherapy
Cryotherapy
Stem Cell Transplantation
Stem Cell Transplantion
Stem Cell Transplantation
Published in: Supportive Care in Cancer / Issue 10/2020
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-019-05258-2

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