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New clinical trial to evaluate paracetamol use during infections after chemotherapy

23 May 2013

Infections are common after strong chemotherapies and can be life threatening.

The infections occur because chemotherapy temporarily weakens the immune system, causing neutropenia [a shortage of a type of white blood cell]. Chemotherapy also damages the lining of the bowel, allowing bacteria to get from the gut into the bloodstream.

The first sign of infection is typically fever - a condition termed 'febrile neutropenia'. Fortunately, most patients respond very well to antibiotics given IV [through the veins], although it usually takes at least a few days in hospital for the infection to clear.

During the infection, and despite appropriate antibiotics, patients often have high fevers. Malaghan Institute Clinical Research Fellow Dr Robert Weinkove, a Consultant Haematologist at the Wellington Blood & Cancer Centre, says that the current practice is to use paracetamol to lower the temperatures of these patients.

“Paracetamol certainly makes people feel better in the short term - I know I use it when I have flu-like symptoms!” he says. “However, there is some evidence that fever is an important part of the body's response to the infection, and that if fever is artificially lowered with paracetamol, the infection takes longer to resolve.”

The question of whether clinicians should continue to use paracetamol during infections after chemotherapy is soon to be investigated in a collaborative clinical trial led by Dr Weinkove, involving the Malaghan Institute, the Medical Research Institute of New Zealand, Capital & Coast District Health Board and the Institute of Environmental Science and Research.

“The trial will recruit patients with infections after chemotherapy,” says Dr Weinkove. “They will all receive appropriate antibiotics. In addition, half will be given paracetamol and half will be given a placebo [dummy] tablet. This is called a randomized placebo-controlled trial, because neither the patients nor their doctors know who has received the paracetamol and who was given the placebo.”

“We will look at the rate of improvement of the infection in these patients, how quickly the bacteria clear from their blood, how long they stay in hospital, how they feel, and how their immune system responds to the infection.”

Dr Weinkove’s study is supported by the Health Research Council of New Zealand and will be conducted in Wellington. It is designed to test the study design and laboratory tests before a much larger clinical trial. If the Wellington study is successful, Dr Weinkove will proceed to the larger trial, which will involve many centres across New Zealand, and possibly Australia.

“By linking laboratory expertise at the Malaghan Institute and ESR, with clinical trials expertise at the Medical Research Institute of New Zealand and Capital & Coast District Health Board, we hope to produce findings that are both clinically relevant and scientifically important,” he says. “This work has the potential to change the way we currently manage infections after chemotherapy.”