ANZCTR search results

Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be effective in controlling cancer in other sites in the body, including the lung and the liver. We aim to test the ability of this new technique to control cancers in the kidney. This is the first step of the research, and is a ‘pilot’ study. Who is it for? You may be eligible to join this study if you are aged greater than 18 years and have a radiological diagnosis or biopsy confirmed diagnosis of either renal cell carcinoma or solitary adrenal metastases. Trial Details If you participate in this study, you will have either a single session of stereotactic body radiotherapy (SBRT) or three sessions of SBRT, depending on how big your cancer is. In order to deliver this treatment, you will need to attend a ‘planning’ session where your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be physically delivered when it comes to the time of treatment. This session will take approximately 45 minutes. When the treatment starts, the total time required to deliver the treatment will be one hour. In addition to the visits required to plan and deliver the radiotherapy, blood samples will be taken as part of this research. These will be taken at the same time as blood is collected to assess your kidney function (which would be standard care). Therefore will not require any additional blood collection visits than would be routinely performed to treat your cancer. Both the kidney function blood sample (standard of care) and the research related blood sample will be taken a total of 3 times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. If you have a primary kidney cancer (renal cell carcinoma), then in addition to the steps outlined above you will have a research related ‘Diffusion weighted-MRI’ scan performed a total of three times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. The Diffusion weighted-MRI scan is similar to a standard MRI scan, but is taken over a longer period of time. Each Diffusion weighted-MRI scan takes approximately 30 minutes. For those patients with adequate kidney function, you will also have a contrast injection at the time of the MRI, which will add an additional 10 minutes to the scan time. The MRI allows us to examine the blood flow into kidneys and the cancer. To assess the function of the kidney after the SBRT treatment, a ‘positron emission tomography’ (PET) scan will be taken at approximately the same timepoints as the perfusion scans; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. This will involve injection of a radioactive tracer and a subsequent scan which will take approximately 30 minutes to capture. This will require you attending the PET Centre for a period of 2 or 3 hours. Participation in this study will involve no extra cost due to either having these scans or the treatment.

Heart surgery is a common procedure, with more than 2500 operations each year in New Zealand. Damage to organs, including kidneys, liver and heart is common after heart surgery and some of the damage may be caused by extra oxygen given on cardiopulmonary bypass. This study will randomise patients to receive normal levels of oxygen or the traditional high levels during heart surgery. Endpoints include a number of blood tests that are very sensitive for detecting damage to the kidney, liver, heart and other organs. In total 286 patients having heart surgery at Auckland City Hospital will be included in this study over a two year period.

The purpose of this pilot study is to is to evaluate and assess a revised enteral nutrition protocol to deliver prescribed volumes of nutritional formula through a cyclic (also known as intermittent) 20-hour continuous method .The current enteral nutrition protocol is based on a 24- hour continuous cycle to deliver prescribed volumes of formula. However, various planned processes and events (such as fasting for endotracheal extubation) often interrupt a 24 hour continuous cycle of feeding potentially resulting in sub-optimal levels of nutrition delivery. Hence, the 20 hour continuous method (with a higher rate of feeding per hour) has been developed so that adequate nutrition can be delivered and planned interruptions can take place within the 4 hour non-feeding “gap” period. a minimum of forty patients will be enrolled from the Monash Medical Centre Intensive Care Unit and will be randomly allocated to a control group ( current 24 hour enteral feeding protocol) or an intervention group (revised 20 hour enteral feeding protocol). Data relating to nutritional and clinical outcomes will be collected for up to 12 days for each participant. The hypotheses is that the new protocol will safely and effectively improve current levels of nutritional adequacy from 48 % (based on local audit) closer to the optimal levels recommended in the literature ( > 80 %) We postulate that this increased provision of calories and protein may translate into improved nutritional and clinical outcomes, but the current study is not powered to demonstrate such a difference.

The purpose of this study is to determine the effect of potassium supplementation in a single meal on blood vessel function. A high potassium intake is associated with reduced risk of heart disease however effect of potassium on blood vessel function is not known. We propose potassium supplementation will improve blood vessel function.

The purpose of this project is to develop a quality of life instrument specific to autoimmune bullous disease. Patients with clinically and histologically diagnose autoimmune bullous disease will be recruited and interviewed regarding the ways their disease affects their quality of life. Based on these responses, a pilot questionnaire will be developed and given to 70 patients. Statistical analysis will then be performed based on the results of these questionnaires to determine whether the instrument is statistically sound or not. If it is validated, the instrument can then be used as a tool to measure quality of life in patients with autoimmune blistering skin diseases.

Obesity in men is one of the greatest public health challenges facing Australia. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death and disability. With 70% of Australian men overweight or obese, the current and predicted financial and human costs are alarming. Despite men being more susceptible than women to many of the serious consequences of obesity such as CVD, men rarely engage in weight loss (WL) programs, and when they do lose weight they rarely maintain the WL. There is an urgent need to develop and evaluate novel and cost effective approaches that achieve long-term WL in men. The aim of this pilot study is to develop and evaluate the feasibility and efficacy of a WL maintenance (WLM) program specifically for men.

The Dietary Approaches to Stop Hypertension (DASH) diet, which is high in fruit, vegetables and dairy and lower in fats, signficantly reduced blood pressure in people without diabetes. At present their has been no investigation of the effect of the DASH diet in people with diabetes. The aim of this pilot study is to investigate the feasibility of a DASH like diet in people with diabetes

The data in this study offer evidence for the value of Spaced Education Diabetes (SED), a tailored, adaptive, online diabetes education program, in improving evidence-based management of type 2 diabetes, by GPs. Spaced Education Diabetes (SED) is an innovative approach that can be delivered by email and tailored to individual GP knowledge levels. It will deliver education to improve management of hyperglycaemia, hypertensive and hyperlipidaemia. The study aims to improve GP management and control of metabolic targets in type 2 diabetics, and improve patient outcomes.

This study aims to investigate the safety, toxicity and efficacy of a treatment combination of the drugs Iodine-131-Rituximab and Panobinostat in patients with Relapsed and Refractory Indolent B-cell Lymphoma. The trial will be conducted in Melbourne at the Peter MacCallum Cancer Centre and in Fremantle at Fremantle Hospital. Who is it for? To be eligible for this study, you must be aged 18 or above with a histologically confirmed relapsed indolent B-cell non Hodgkin's lymphoma. Further details of the inclusion criteria for this trial can be found in the corresponding section of this trial record. Trial Details There are two phases for this study, with three dose levels of panobinostat considered in phase I of the study, which is the dose finding phase. This will be followed by phase II, which consists of an expanded cohort at the phase I determined dose of panobinostat. In phase I, you will receive oral panobinostat which will be administered at a dose of 20, 30 or 40mg in 5, 15 and 20mg tablets. This will commence on day one on a Monday and will continue to be given on Monday, Wednesday and Friday weekly for four weeks. A tracer activity of 200 MBq131I-rituximab will then be administered intravenously after an intravenous dose of 375 mg/m2 rituximab unlabeled antibody, with both given on day four. Whole-body imaging and background scans will be performed within one hour in the administering department, and be repeated four and seven days later under the same imaging conditions. Full details of the treatment regime can be found in the Description of intervention(s)/ Exposure field of this trial record.

Childhood Apraxia of Speech (CAS) is a motor speech disorder. Children with CAS have difficulties planning the movements required for speech sounds and melody. The difficulties associated with CAS often persist through life and are deterimental to academic, social and vocational development, despite normal intelligence. Currently a number of single case designs are available yet few treatments have been tested or replicated. We intend to complete the first randomised control trial to compare two treatments for CAS. The speech therapy treatments we want to compare are 1) the Rapid Syllable Transition Treatment (Ballard et al, 2010) and 2) the Nuffield Dyspraxia Programme (3rd edition) (Williams & Stephens, 2004). Both treatments have preliminary promising evidence. We want to know if these treatments improve speech sounds and melody in children with CAS age 4-12 years. We also want to know which treatment will make better gains in treated sounds/words/sentences AND untreated but similar sounds/words/sentences.