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

Autor: Kamsvåg T; Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden. tove.kamsvag_magnusson@kbh.uu.se., Svanberg A; Department of Medical Sciences, Uppsala University, Uppsala, Sweden., Legert KG; Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden., Arvidson J; Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden., von Essen L; Department of Women's and Children's Health, Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden., Mellgren K; Department of Pediatric Oncology, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden., Toporski J; Department of Clinical Sciences, Pediatric Oncology and Hematology, University of Lund, Lund, Sweden., Winiarski J; Department of Pediatrics, Astrid Lindgren's Children's Hospital, Karolinska University Hospital, Huddinge, Stockholm, Sweden.; Department of Clintec, Karolinska Institutet, Stockholm, Sweden., Ljungman G; Department of Women's and Children's Health, Pediatric Oncology, Uppsala University, Uppsala, Sweden.
Jazyk: angličtina
Zdroj: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [Support Care Cancer] 2020 Oct; Vol. 28 (10), pp. 4869-4879. Date of Electronic Publication: 2020 Jan 28.
DOI: 10.1007/s00520-019-05258-2
Abstrakt: 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.
Databáze: MEDLINE
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