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

Kamsvåg, Tove ; Svanberg, Anncarin ; Legert, Karin Garming ; Arvidson, Johan ; von Essen, Louise ; Mellgren, Karin ; Toporski, Jacek LU ; Winiarski, Jacek and Ljungman, Gustaf (2020) In Supportive Care in Cancer
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... (More)

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. 

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organization
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type
Contribution to journal
publication status
epub
subject
keywords
Children, Feasibility, Hematopoietic stem cell transplantation, Oral cryotherapy, Oral mucositis
in
Supportive Care in Cancer
publisher
Springer
external identifiers
  • pmid:31993753
  • scopus:85078458351
ISSN
0941-4355
DOI
10.1007/s00520-019-05258-2
language
English
LU publication?
yes
id
dd412ad1-f303-4a80-91b9-12c3bcd940b5
date added to LUP
2020-02-06 14:37:52
date last changed
2020-11-24 03:46:22
@article{dd412ad1-f303-4a80-91b9-12c3bcd940b5,
  abstract     = {<p>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 &lt; 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. </p>},
  author       = {Kamsvåg, Tove and Svanberg, Anncarin and Legert, Karin Garming and Arvidson, Johan and von Essen, Louise and Mellgren, Karin and Toporski, Jacek and Winiarski, Jacek and Ljungman, Gustaf},
  issn         = {0941-4355},
  language     = {eng},
  month        = {01},
  publisher    = {Springer},
  series       = {Supportive Care in Cancer},
  title        = {Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations—a feasibility study and randomized controlled trial},
  url          = {http://dx.doi.org/10.1007/s00520-019-05258-2},
  doi          = {10.1007/s00520-019-05258-2},
  year         = {2020},
}