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Quality of life in paediatric solid tumours: a randomised study of metronomic chemotherapy versus placebo
  1. Raja Pramanik1,
  2. Sandeep Agarwala2,
  3. Vishnubhatla Sreenivas3,
  4. Deepa Dhawan1 and
  5. Sameer Bakhshi1
  1. 1 Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, Delhi, India
  2. 2 Department of Pediatric Surgery, All India Institute of Medical Sciences, New Delhi, Delhi, India
  3. 3 Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, Delhi, India
  1. Correspondence to Dr Sameer Bakhshi, Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, Delhi 110 029, India; sambakh{at}hotmail.com

Abstract

Objective Health-related quality of life (HRQoL) is an important outcome for paediatric cancer studies. We compared the HRQoL between patients of progressive paediatric solid tumours randomised to metronomic chemotherapy versus placebo.

Methods In this double-blinded, placebo-controlled randomised study of 108 children with progressive malignancies, HRQoL was evaluated using the PedsQOL Cancer module V.3 at baseline (A1), A2 (9 weeks or earlier if progressed) or A3 (18 weeks or earlier if progressed).

Results There was no statistically significant difference in the change in quality of life produced by each arm from A1 to A2 in either mean total scores or individual domain scores, reported by children or their parents. On analysing the response according to the minimal clinically important difference, defined as an improvement by 4.5 points, we found no significant differences, be it among bone-sarcomas, other tumours, responders (those who received ≥9 weeks of treatment) or non-responders.

Conclusions The present study concludes that there was no significant difference in HRQoL, between the patients in the two arms at second and later assessments. This is consistent with the other survival endpoints in the study.

Trial registration number Clinical trial registration: clinicaltrials.gov Identifier: NCT01858571.

  • cancer
  • paediatrics
  • quality of life

https://doi.org/10.1136/bmjspcare-2020-002731

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    Footnotes

    • Contributors All authors contributed to the concept design and conduct of the study. DD randomised the patients. VS and RP did the statistical analysis.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • 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.