Paracetamol in febrile neutropenia feasibility study
A randomised placebo-controlled trial of paracetamol in febrile neutropenia: feasibility study
Malaghan Institute of Medical Research
50 participants
Oct 8, 2013
Interventional
Conditions
Summary
The aim of the study is to discover the impact of using paracetamol during febrile neutropenia, a common type of infection after chemotherapy. At present, about half of patients receive paracetamol to lower their temperature during febrile neutropenia in our hospital department. Whether or not someone receives paracetamol is at the discretion of the patient’s doctor or nurse. We do not know whether paracetamol is beneficial or not. On the one hand, paracetamol can lower fevers and can make people feel more comfortable. On the other hand, fevers are part of the body’s natural response to an infection and lowering a fever with paracetamol might delay recovery from an infection. We propose a large study to answer the question of whether paracetamol should be used in febrile neutropenia or not. However, before we can do the large study necessary to answer this question, we need to do a smaller study (this study) to ensure that the large study can be achieved. Specifically, we need to check that people receiving paracetamol have a lower temperature than those receiving placebo, that the study treatment is acceptable, that we can detect bacteria in the blood at low levels, and that we can recruit enough patients for the large study.
Eligibility
Inclusion Criteria8
- 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)
- Aged 18 years or over
- Weight 50 kg or over
- Geographically accessible to the Wellington Blood and Cancer Centre in the event of febrile neutropenia onset
- 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 Criteria8
- 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)
- Any known contraindication to paracetamol 4 g daily
- Severe functional impairment that confines the patient to bed or chair for 50% or more of waking hours
- Pregnancy
- Allogeneic stem cell transplantation within the 12 months before study entry
- Active graft versus host disease
- Active hepatitis B, hepatitis C or HIV (HBsAg positive, anti-HCV positive or anti-HIV positive)
- Previous randomisation into this feasibility study
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Interventions
Patients due to receive chemotherapies carrying a high risk of febrile neutropenia will be screened and will give informed consent before febrile neutropenia onset. Patients who consent to the study will be randomised on a 1:1 ratio to receive oral paracetamol (1g six hourly) or matching placebo during the first 42 hours of febrile neutropenia. Upon the development of febrile neutropenia patients will commence their allocated treatment after starting antibiotic therapy. Whilst in hospital with febrile neutropenia, study participants will have daily blood tests over and above those taken for standard of care. Tests will look at markers of inflammation and the level of bacteria in participants’ blood. Participants will also be asked to fill in a short quality of life questionnaire each day. On the third day, two more detailed quality of life questionnaires and a questionnaire about their experience of the study will need to be completed. All participants will be inpatients in Wellington hospital. Adherence to study treatment will be monitored by reviewing the participants' medication chart, as the study treatment/placebo will be prescribed on this and individual doses will be signed for by the administering nurse or doctor. If a participant is discharged home prior to completing the course of study treatment, that participant will come off study.
Locations(1)
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ACTRN12613000601730