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Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study
Hadeel Hassan1,2, Sally Kinsey3,4, Bob Phillips5
1Leeds Institute of Cancer and Pathology, University of Leeds, Faculty of Medicine and Health, Leeds, UK hadeelhassan@doctors.org.uk.
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.
