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Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study
  1. Hadeel Hassan1,2,
  2. Sally Kinsey1,3,
  3. Bob Phillips4
  1. 1Leeds Institute of Cancer and Pathology, University of Leeds, Faculty of Medicine and Health, Leeds, UK
  2. 2Paediatric Haematology and Oncology, Leeds General Infirmary, Leeds, UK
  3. 3Paediatric Haematology, Leeds General Infirmary, Leeds, West Yorkshire, UK
  4. 4Centre for Reviews and Dissemination, University of York Alcuin College, York, UK
  1. Correspondence to Dr Hadeel Hassan, University of Leeds Faculty of Medicine and Health, Leeds LS2 9JT, UK; hadeelhassan{at}doctors.org.uk

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.

  • qualitative research
  • data collection

Data availability statement

Data may be obtained from a third party and are not publicly available. The protocol for this study is accessible online.

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Data availability statement

Data may be obtained from a third party and are not publicly available. The protocol for this study is accessible online.

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Footnotes

  • Twitter @hhassan90210, @drbobphillips

  • Contributors HH designed and undertook the research described in this and also wrote the first and repeated drafts of this manuscript. BP and SK both supervised HH while undertaking this study and also gave feedback for the initial and subsequent manuscript drafts.

  • Funding This work was supported by Candlelighters charity who funded Dr Hadeel Hassan’s PhD, for which this research was conducted. Symprove company donated the probiotic and placebos free of charge and gave a voluntary donation to the development of the web-app.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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