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 language | English |
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Pages (from-to) | 259-264 |
Journal | Archives of Disease in Childhood |
Volume | 107 |
Issue number | 3 |
Early online date | 30 Jun 2021 |
DOIs | |
Publication status | Published - Mar 2022 |