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

Malaghan Institute of Medical Research0 个研究点目标入组 37 人开始时间: 2013年5月27日最近更新: 2020年1月13日

试验速览

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•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

•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

发起方

Malaghan Institute of Medical Research