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Clinical Trials/ACTRN12613000601730
ACTRN12613000601730
Completed
Phase 2

A randomised placebo-controlled trial of paracetamol in febrile neutropenia: feasibility study

Malaghan Institute of Medical Research0 sites37 target enrollmentMay 27, 2013
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Malaghan Institute of Medical Research
Enrollment
37
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 27, 2013
End Date
July 13, 2015
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Malaghan Institute of Medical Research

Eligibility Criteria

Inclusion Criteria

  • •1\.Scheduled to receive a chemotherapy carrying a high risk (\> 50%) of febrile neutropenia, such as: acute leukaemia intensive induction and consolidation, autologous stem cell transplantation, high\-dose anthracycline\-based regimen for aggressive lymphoma (Hyper\-CVAD, Nordic MCL2, CODOX\-M IVAC, GMALL 07/2003\)
  • •2\.Aged 18 years or over
  • •3\.Weight 50 kg or over
  • •4\.Geographically accessible to the Wellington Blood and Cancer Centre in the event of febrile neutropenia onset
  • •5\.Satisfactory liver and renal function as indicated by:
  • •i.Alanine Transaminase (ALT) less than or equal to 2 x Upper Limit of Normal (ULN)
  • •ii.Alkaline Phosphatase (ALP) less than or equal to 2 x ULN
  • •iii.Bilirubin less than or equal to 1\.5 x ULN

Exclusion Criteria

  • •1\.Patient using regular paracetamol (1 g or more on at least seven days over the 14 days before study entry) or regular non\-steroidal anti\-inflammatory drugs (on at least seven days over the 14 days before study entry; low dose aspirin \< 100 mg/day is permitted)
  • •2\.Any known contraindication to paracetamol 4 g daily
  • •3\.Severe functional impairment that confines the patient to bed or chair for 50% or more of waking hours
  • •4\.Pregnancy
  • •5\.Allogeneic stem cell transplantation within the 12 months before study entry
  • •6\.Active graft versus host disease
  • •7\.Active hepatitis B, hepatitis C or HIV (HBsAg positive, anti\-HCV positive or anti\-HIV positive)
  • •8\.Previous randomisation into this feasibility study

Outcomes

Primary Outcomes

Not specified

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