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

Details

Title
Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations—a feasibility study and randomized controlled trial
Author
Kamsvåg Tove 1   VIAFID ORCID Logo  ; Svanberg Anncarin 2 ; Legert, Karin Garming 3 ; Arvidson Johan 1 ; von Essen Louise 4 ; Mellgren, Karin 5 ; Toporski Jacek 6 ; Winiarski Jacek 7 ; Ljungman Gustaf 1 

1  Uppsala University, Department of Women’s and Children’s Health, Pediatric Oncology, Uppsala, Sweden (GRID:grid.8993.b) (ISNI:0000 0004 1936 9457) 
2  Uppsala University, Department of Medical Sciences, Uppsala, Sweden (GRID:grid.8993.b) (ISNI:0000 0004 1936 9457) 
3  Karolinska Institutet, Department of Dental Medicine, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626) 
4  Uppsala University, Department of Women’s and Children’s Health, Clinical Psychology in Healthcare, Uppsala, Sweden (GRID:grid.8993.b) (ISNI:0000 0004 1936 9457) 
5  University of Gothenburg, Department of Pediatric Oncology, Institute of Clinical Sciences, Gothenburg, Sweden (GRID:grid.8761.8) (ISNI:0000 0000 9919 9582) 
6  University of Lund, Department of Clinical Sciences, Pediatric Oncology and Hematology, Lund, Sweden (GRID:grid.4514.4) (ISNI:0000 0001 0930 2361) 
7  Karolinska University Hospital, Department of Pediatrics, Astrid Lindgren’s Children’s Hospital, Stockholm, Sweden (GRID:grid.24381.3c) (ISNI:0000 0000 9241 5705); Karolinska Institutet, Department of Clintec, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626) 
Pages
4869-4879
Publication year
2020
Publication date
Oct 2020
Publisher
Springer Nature B.V.
ISSN
09414355
e-ISSN
14337339
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1007/s00520-019-05258-2
ProQuest document ID
2436973300
Copyright
© The Author(s) 2020. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.