Sentinel Node Biopsy Versus Axillary Clearance In Early Breast Cancer: The SNAC Trial
Funder
National Health and Medical Research Council
Funding Amount
$1,257,525.00
Summary
Over 10,000 Australian women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spread to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. This study compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) ....Over 10,000 Australian women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spread to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. This study compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary clearance and 2) sentinel node biopsy. Axillary clearance involves removal of most lymph nodes in the armpit. In sentinel node biopsy only a few lymph nodes most closely related to the breast cancer are removed. Axillary clearance is the current standard operation. However, it is associated with risks including infection, pain, stiffness, numbness and lymphoedema (arm swelling). Lymphoedema may occur in 5-50% of women treated for breast cancer and can cause major symptoms and disabilities. In many women the breast cancer has not spread to the lymph nodes, and axillary clearance is unnecessary. Recent studies suggest sentinel node biopsy may provide as much information as axillary clearance. Scans and dye are used to help locate the sentinel nodes. Minimising the amount of surgery to the armpit should reduce the side effects. However, the long term safety and effectiveness of removing only a few nodes is unknown. This trial will determine if sentinel node biopsy reduces lymphoedema and gives equivalent cure rates. If it does, then it should become standard practice. The study compliments comparable studies being done in US, UK and Europe by providing unique information about symptoms and quality of life from the women's perspective. One thousand Australian women will take part. The is study is being conducted by Australian breast surgeons under the auspices of the Royal Australasian College of Surgeons and the NHMRC Clinical Trials Centre.Read moreRead less
Effective Management Of Acute Whiplash Injuries Requires A Pragmatic Approach: An RCT With Stratified Treatments
Funder
National Health and Medical Research Council
Funding Amount
$382,550.00
Summary
Whiplash injuries from a motor vehicle crash continue to incur substantial personal and financial costs to the community and the insurance industry. The current approaches to an acute whiplash injury in Australia and internationally have failed to lessen the rate of how many people develop chronic neck pain. Between 40 and 60% still have pain 6 months after injury. Motor Accident Insurance Commission (Qld) figures indicate that 20% of patients with chronic whiplash account for 60% of the costs. ....Whiplash injuries from a motor vehicle crash continue to incur substantial personal and financial costs to the community and the insurance industry. The current approaches to an acute whiplash injury in Australia and internationally have failed to lessen the rate of how many people develop chronic neck pain. Between 40 and 60% still have pain 6 months after injury. Motor Accident Insurance Commission (Qld) figures indicate that 20% of patients with chronic whiplash account for 60% of the costs. Transition from an acute to a chronic condition must be prevented. A new direction in management in the acute stage is urgently required as once the pain has become chronic, it is difficult to help. This research will conduct a novel randomised controlled trial for acute whiplash. It will test individually prescribed multi-professional management against usual care with the aim to lessen the numbers who go on to develop chronic pain. It will be the first clinical trial that acknowledges from the outset that the whiplash injuries and affects people in different ways. Our previous research with acute whiplash patients has documented the variations in presentation from physical, physiological and psychological perspectives. In this trial, management will be prescribed as directed by measurable pain, muscle and psychological impairments in the individual, rather than regard all patients as the same as in other trials. This trial will offer individualised treatments; medical, physiotherapy and-or psychological using an empirically derived treatment algorithm. Cost-effectiveness of the program will be evaluated against that incurred during usual care. It is predicted that early multi-professional management will be less expensive in the long term than existing approaches. This RCT stands to extend knowledge in the management of whiplash associated disorders (WAD).Read moreRead less
New Methods And Guidelines For The Design, Analysis And Reporting Of Cluster-crossover And Stepped Wedge Randomised Trials In Clinical And Public Health Research
Funder
National Health and Medical Research Council
Funding Amount
$391,258.00
Summary
Cluster crossover and stepped wedge designs have emerged recently as study designs used in clinical and public health research settings. However, despite their use there has been very little methodological assessment of the statistical analysis methods used in current practice. The proposed research will assess the correctness of current methods and will produce a toolkit of state-of-the art, defensible trial design, analysis and reporting methods for the clinical/health researcher.
Plasma Exchange And Glucocorticoids In ANCA Associated Vasculitis: A Randomised Controlled Trial (PEXIVAS Australia)
Funder
National Health and Medical Research Council
Funding Amount
$635,243.00
Summary
Vasculitis is a life-threatening disease, and the current treatment for this condition is not satisfactory. This clinical trial aims to determine 1) if plasma exchange can lower mortality and the development of severe kidney failure due to this disease, and 2) if the use of lower doses of corticosteroids can lessen the infectious complications of treatment. This trial is part of a major international effort which will involve a total of 500 patients from Australia, UK, Europe, USA and NZ.
Large-scale Randomised Evidence: The Reliable Detection Or Refutation Of Treatment Effects Through Large, Simple Randomised Trials And Collaborative Meta-analyses Of Trials Using Individual Participant Data
Funder
National Health and Medical Research Council
Funding Amount
$425,897.00
Summary
Randomised controlled trials are the most reliable scientific method of studying medical treatments. Well-designed trials are thus needed to confidently guide doctors, other health professionals and policy-makers, particularly for common conditions such as cardiovascular disease. This Fellowship will study how we can better prevent and treat cardiovascular disease through the design, conduct and analysis of such trials at the University of Oxford, a world-leader in randomised controlled trials.
A Randomised Controlled Trial Of The Effect Of Hydrocortisone On Mortality In Critically Ill Patients With Septic Shock
Funder
National Health and Medical Research Council
Funding Amount
$3,432,452.00
Summary
This study performed across Australia and New Zealand will evaluate whether hydrocortisone, a cheap drug when administered to critically ill patients with severe infection, will save lives.
VITATOPS - A Randomised Controlled Trial Of Vitamins To Prevent Stroke
Funder
National Health and Medical Research Council
Funding Amount
$391,364.00
Summary
A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS ....A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS study arises from a large body of consistent, biologically plausible evidence linking homocysteine in a dose-dependent fashion to stroke and other types of vascular disease. A simple, non-toxic, and inexpensive intervention in the form of multivitamins (folate, B6 and B12) has been shown to be highly effective at reducing homocysteine levels, irrespective of the underlying cause. All patients who are referred to a neurologist or general physician in one of the collaborating centres within six months of a stroke or transient ischaemic attack are eligible for the trial. In total, treatment will continue for a period of between 1 and 5 years. During this time, patients will be closely monitored in order to record the occurrence of any vascular events (particularly strokes and heart attacks). Neither the study investigator nor the patient will know which treatment they are receiving (i.e. it is 'double blind'). The number of vascular events in the treatment groups will be compared at the end of the study in order to determine whether vitamin treatment is beneficial. This application is for five years of support to allow the investigators to move from the pilot phase of VITATOPS in Perth to begin recruitment to the definitive trial in other centres across Australia and New Zealand. This study may have a major impact on patient management. If vitamins prove to be effective, we may recommend vitamin supplementation to all of our stroke patients in the future.Read moreRead less
A Randomised Placebo-controlled Crossover Trial Of Micronised Resveratrol As A Treatment For Friedreich Ataxia
Funder
National Health and Medical Research Council
Funding Amount
$556,287.00
Summary
Friedreich ataxia (FRDA) is the most common inherited cause of ataxia (incoordination). There are currently no treatments proven to slow or reverse its inexorable progression. We have shown that resveratrol holds promise as a treatment in an open-label study and now propose a placebo controlled study that will provide evidence of whether resveratrol can slow or reverse symptoms in this devastating disorder.