1. Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study.
- Author
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Hassan, Hadeel, Kinsey, Sally, and Phillips, Bob
- Subjects
CHILDHOOD cancer ,MUCOSITIS ,PROBIOTICS ,PEDIATRIC oncology ,FEASIBILITY studies - Abstract
Background: A recent systematic review and meta-analysis identified a paucity of randomised-controlled trials (RCTs) investigating the use of probiotics to reduce or prevent mucositis and infection in children with cancer.Objective: This study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.Setting: The Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.Patients: Children aged 1 year or older, receiving chemotherapies likely to cause mucositis.Interventions: Participants were randomised to receive the probiotic or placebo on day 1-14 of a chemotherapy cycle. Participants were also required to complete a patient diary for 21 days.Main Outcome Measures: To assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.Results: Between May and November 2019, 34 out of 39 eligible participants were approached. Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew. Seven participants partially completed the diary but only two participants completed 80% or more. Eligible participants appeared to prefer giving informal verbal feedback when in direct contact with research and healthcare professionals.Conclusion: This study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.Trial Registration Number: NCT03785938. [ABSTRACT FROM AUTHOR]- Published
- 2022
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