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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. 1Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, Delhi, India
  2. 2Department of Pediatric Surgery, All India Institute of Medical Sciences, New Delhi, Delhi, India
  3. 3Department 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

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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.

  • Patient consent for publication Not required.

  • Ethics approval The study protocol was approved by the Institute Ethics Committee vide letter number: IEC/NP-63/2013 & RP-35/05.08.2013.

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