Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study

Abstract

BackgroundA 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.ObjectiveThis 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.SettingThe Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.PatientsChildren aged 1 year or older, receiving chemotherapies likely to cause mucositis.InterventionsParticipants 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 measuresTo assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.ResultsBetween 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.ConclusionThis study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.Trial registration numberNCT03785938.