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

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 Electronic supplementary material The online version of this article (10.1007/s00520-019-05258-2) contains supplementary material, which is available to authorized users.

The efficacy of two different oral hygiene regimens on the incidence and severity of oral mucositis in pediatric patients receiving hematopoietic stem cell transplantation: A prospective interventional study

“…It is defined as an inflammation of oropharynx resulting from cancer therapy typically manifesting as atrophy, swelling, erythema and ulceration 1 . It affects 80% of children undergoing HSCT, 3 and usually occurs between two and 18 days following the initiation of the chemotherapy 2 . It is generally accepted that the pathophysiology of OM is a complex multistage phenomenon that can result from damage to the oral mucosal cells by free radicals produced by the drugs used in chemotherapy 4 .…”

Effects of cryotherapy on high‐dose melphalan‐induced oral mucositis in pediatric patients undergoing autologous stem cell transplantation

“…As previously reported in adult patients, 19 60 min of cryotherapy was sufficient for pediatric patients receiving a 30‐min intravenous infusion of MEL; however, this procedure is still uncomfortable, particularly for infants and young children 23 . MEL may be safely administered by a bolus intravenous injection that may increase compliance to the procedure and thus, decrease the incidence of OM by shortening the duration of cryotherapy.…”

Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil

“…Measurement of mucositis: mucositis was evaluated for both experimental and control groups, according to the World Health Organization (WHO) mucositis assessment scale (9) , a scale considered ideal because it incorporates both clinical and functional factors, and has its validity established in several studies on the theme (8,(11)(12)(13) . On this scale, mucositis is classified into four grades, namely: Grade 0: no changes; Grade 1: erythema; with or without pain; Grade 2: erythema, ulcers, the patient can eat a solid diet; Grade 3: ulcers, extensive erythema, the patient is unable to eat a solid diet; Grade 4: extensive mucositis that does not allow oral feeding.…”