Paracetamol in febrile neutropenia feasibility study

Phase 2

Completed

• Conditions: Infection: febrile neutropenia after intensive chemotherapy; Cancer - Leukaemia - Acute leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12613000601730
• Lead Sponsor: Malaghan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-27
• Study Completion: 2015-07-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified