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
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 COMMUNITY BASED STRENGTH TRAINING PROGRAM TO IMPROVE WORK TASK PERFORMANCE IN YOUNG ADULTS WITH DOWN SYNDROME
Funder
National Health and Medical Research Council
Funding Amount
$180,649.00
Summary
This study will compare the outcomes of a 10 week twice a week community-based weight training program for young adults with Down syndrome with an art program. It will establish if a student-led exercise program can improve their performance of work tasks and their activity levels. Should the program prove beneficial, we aim to achieve the long-term outcome of exercise being implemented as a sustainable, inclusive recreation option for this group.
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
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.
Neural Changes Associated With Symptom Improvement In Posttraumatic Stress Disorder Following Exposure Treatment
Funder
National Health and Medical Research Council
Funding Amount
$223,855.00
Summary
Posttraumatic stress disorder (PTSD) is a chronic disorder with enormous psychological, social and economic consequences that affects approximately 10-15% of Australians. Recent international research is focused on identifying mechanisms underlying effective treatments of PTSD, in an attempt to understand both the processes that maintain PTSD, and to help target more precise interventions to prevent chronic PTSD, a disabling condition that creates an enormous economic burden on health and compen ....Posttraumatic stress disorder (PTSD) is a chronic disorder with enormous psychological, social and economic consequences that affects approximately 10-15% of Australians. Recent international research is focused on identifying mechanisms underlying effective treatments of PTSD, in an attempt to understand both the processes that maintain PTSD, and to help target more precise interventions to prevent chronic PTSD, a disabling condition that creates an enormous economic burden on health and compensation systems. This project will be the first study to identify the neural mechanisms underlying effective exposure-based treatment of PTSD. Exposure-based treatments are the current treatments of choice for PTSD, with several studies showing them to be highly effective in treating PTSD. Yet, the mechanisms and agents of change underlying this effective treatment remain unknown. Exploring the neural networks associated with effective treatment and symptom change will help identify and elucidate the mechanisms underlying exposure treatment. This has critical clinical implications, enabling insight into biological mechanisms underlying PTSD, more precise identification of populations that are less responsive to standard exposure-based treatments, and eventually will lead to better targeted and more effective treatment of chronic PTSD.Read moreRead less