Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2020
Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01789658 (A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Controlled Trial of Cryotherapy for Prevention and Reduction of Severity of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Oral cryotherapy for management of chemotherapy-induced oral mucositis in haematopoietic cell transplantation: a systematic review.BMC cancer · 2022Pooled it
- Prevention and Treatment of Oral Mucositis in Pediatric Patients: Systematic Review and Meta-Analysis of Randomized Controlled Trials.In vivo (Athens, Greece)Pooled it
- Effectiveness of oral cryotherapy in preventing methotrexate-induced oral mucositis in pediatric patients with acute lymphoblastic leukemia: a randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Trial
- 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.Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry · 2020Trial
- Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil.Revista latino-americana de enfermagem · 2020Trial
- Oral disease burden in children and adolescents scheduled for allogeneic haematopoietic stem cell transplantation: a multicentre study.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2026Article
- Recent advances in oral cryotherapy for the management of anticancer therapy-induced oral mucositis.Future science OA · 2025Review
- Effectiveness of cryotherapy in preventing oral mucositis in pediatric cancer patients in Jordan: a randomized controlled trial.Child health nursing research · 2024Article
- A Narrative Review of Pain in Pediatric Oncology: The Opioid Option.Paediatric drugs · 2024Review
- Review
- Interventions for the Prevention of Oral Mucositis in Patients Receiving Cancer Treatment: Evidence from Randomised Controlled Trials.Current oncology (Toronto, Ont.) · 2023Review
- Prevalence and risk factors of oral mucositis in paediatric patients undergoing haematopoietic stem cell transplantation.Oral diseases · 2022Article
- MASCC/ISOO clinical practice guidelines for the management of mucositis: sub-analysis of current interventions for the management of oral mucositis in pediatric cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Article
- Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers.Medical oncology (Northwood, London, England) · 2020Article
- Oncological-Therapy Related Oral Mucositis as an Interdisciplinary Problem-Literature Review.International journal of environmental research and public health · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 1 country.
Funding
Abstract
purposeTo 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).
methodsFifty-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.
resultsForty-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.
conclusionThe 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 registrationClinicalTrials.gov id: NCT01789658.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.