CURRENT STUDIES
The Australasian Malignant Pleural Effusion (AMPLE) Trial - 2 / ACTRN12615000963527
Malignant pleural effusions (MPE) can complicate most cancers, causing dyspnea and impairment in quality of life (QoL). Indwelling pleural catheters (IPC) are a novel management approach allowing ambulatory fluid drainage, fewer invasive procedures and reduced hospitalizations than conventional talc pleurodesis.
IPC drainage approaches however vary greatly between centres and have direct impact on patient care and major implications on healthcare resources. Some centres advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages demand considerably more time, manpower and costs and may increase risks of complications. Other centres believe that MPE care should be symptom-based and drainage performed accordingly (often weekly to monthly).
The Australian Malignant PLeural Effusion (AMPLE) trial-2 is a multi-centre, open-labeled, randomized trial. Patients (n=86) with MPEs will be randomized 1:1 to either aggressive (daily) or symptom-guided drainage regimes after IPC insertion, with the aim to determine which regime is superior in improving clinical outcomes. The primary outcome is the mean daily dyspnea score, measured by a 100mm visual analogue scale (VAS), over the first 60 days. Secondary outcomes include benefits on activity levels, complications, hospital days, health costs, and QoL measures.
The study will build on the recently completed AMPLE-1 study (146 MPE patients recruited over 27 months) and involves centres in Australia, New Zealand, Malaysia and Hong Kong. This study is powered (5% significance, 90% power) to detect a mean difference of VAS score of 14mm between groups and allows a 10% drop-out rate. This study addresses an urgent and practical question pertinent to the care of MPE; the results will add useful information to guide clinical practice.
Feasibility and efficacy of exercise in the management of malignant pleural mesothelioma - a collaborative study with Dr Carolyn McIntyre of Edith Cowan University Health and Wellness Institute.
Publicity articles (2016):
http://health.thewest.com.au/news/2994/fit-to-beat-cancer
http://health.thewest.com.au/news/2993/work-out-the-best-way-to-survive-cancer
Fit to beat cancer
Andrew Hickson isn’t sure if his childhood rock collection including a nice sample of blue asbetsos is to blame or helping his dad cut up asbestos sheets or Guy Fawkes’ nights when anything was thrown on the bonfire, including pieces of asbestos - but at some point he inhaled blue asbestos fibres into his lungs.
In February, the terrible consequences of that were finally realised when he was diagnosed with epithelioid mesothelioma.
Mr Hickson, 67, a sculptor whose works include the Wagin ram, understands the prognosis is not good but he refuses to dwell on it — or research it on Dr Google.
“Ignorance is bliss, I just don’t want to know about it, which I know is a bit extreme but there are so many differing opinions and bits of information. Also, mentally if I don’t have all that information then it is baggage I don’t have to carry,” he says.
Mr Hickson is instead focused on a new exercise plan.
He has signed up to a research trial testing whether exercise can improve quality of life for mesothelioma patients and those with other pleural cancers and now goes to the gym three times a week to complete a program designed specifically for him.
“I’m finding it very stimulating and enjoyable and it just makes me feel a whole lot more positive about everything, I’m using muscles that I haven’t hardly used,” he says.
Mr Hickson estimates his lung capacity is about 90 per cent at the moment and he is not in any pain. “I’m feeling more pumped than I probably have in years so how it all unfolds is obviously a different story but at this stage I am asymptomatic really.”
Gary Lee, director of the Pleural Medicine Unit at Sir Charles Gairdner Hospital, says there is no cure for mesothelioma.
The only treatment proven to extend life is chemotherapy, which studies show can give an extra three months on average, but comes with side effects.
“The hope is that appropriate exercise and activity can improve patients’ sense of wellbeing, improve their functional levels, improve their fitness and therefore they have a better quality of life and can better withstand any effects of chemotherapy,” he said.
Preliminary studies show activity levels of mesothelioma patients are very low, making them good candidates to see if exercise helps.
Patients enrolled in the study are given an individualised program and then undergo a range of tests to assess their quality of life before they exercise and afterwards.
“If it does scientifically prove that there are significant advantages to exercise, then we might be able to get more resources to help people get out of the house,” Professor Lee says.
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Research has demonstrated that exercise is a safe and effective intervention for the management of various adverse effects associated with cancer and cancer treatments. However, this informationis based on research studies involving predominantly breast and prostate cancer patients. The purpose of this research is to find out if a short, supervised exercise program could be useful for people with mesothelioma and malignant pleural effusions.
30 people with mesothelioma or a malignant pleural effusion will be recruited over 12 months to undertake a 6-week exercise program. The program involves 3 supervised exercise sessions each week of resistance exercise. The exercise prescription will be progressive and modified according to the individual response. The following outcomes will be assessed: quality of life, physical functioning, cardiorespiratory fitness, body composition, physical activity level, strength and feasibility of the program.
Primary Spontaneous Pneumothorax Trial
The Pleural Medicine Unit (PMU) is supporting this multicentre Australasian trial coordinated by the Centre for Clinical Research in Emergency Medicine (CCREM) at Royal Perth Hospital. At SCGH the PMU will be involved with the follow-up of participants following their recruitment and randomisation in the Emergency Department.
Primary spontaneous pneumothorax (PSP) is a significant global health problem affecting adolescents and young adults. Current management is variable, with sparse evidence from randomised controlled trials to guide treatment. Current guidelines emphasize the importance of intervention in most patients, which involves insertion of a chest drain, hospital admission, and thoracic surgery in some. This approach has recently been questioned and there is evidence to suggest that conservative management without intervention is effective and safe. The risk of recurrence may also be lower with conservative treatment because of better healing of the lung defect during slow re-expansion of the lung.
The trial proposes to address the fundamental management question of conservative versus invasive management in a multicentre randomised controlled trial that will be the largest study of PSP ever undertaken. It has the potential to reduce morbidity and deliver economic benefits through reductions in procedures, complications and hospital admissions.