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

Hadeel Hassan, Sally Kinsey, Bob Phillips

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)259-264
JournalArchives of Disease in Childhood
Volume107
Issue number3
Early online date30 Jun 2021
DOIs
Publication statusPublished - Mar 2022

Bibliographical note

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

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