ANZCTR search results

This study looks at the role of exercise in improving the quality of life in prostate cancer patients commencing treatment with the drug Lucrin. Who is it for? You can join this study if you are a man with prostate cancer which has not spread to distant sites (metastases) and you are about to begin therapy with the hormonal treatment Lucrin. Trial details: Participants will be divided into two groups. One group will take part in progressive supervised resistance & aerobic exercises (e.g. upper and lower body resistance-based exercise using weight machines as well as aerobic exercise including walking, jogging, cycling and rowing) twice weekly (60 minutes session) for 12 weeks. The second group will receive usual care only for 12 weeks and then will take part in the 12 week exercise program. Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30). Physical and muscle function, body composition and psychological distress will also be assessed.

The treatment known as selective internal radiation therapy, or SIRT has been used in human patients since 1998 for the treatment of liver cancer. This study will be the first time that SIRT treatment has been used in human patients for the treatment of kidney cancer. The primary purpose of this study is to test the safety of SIRT as a treatment for patients with kidney cancer (also known as renal cell carcinoma) that is not suitable for treatment using the standard treatment options available. While SIRT treatment has been used for over a decade to treat liver cancer, it has not been used before to treat kidney cancer. In this study, four separate groups of patients will be entered into the study. The four groups of patients will each receive a certain dose of selective internal radiation therapy for their kidney cancer. The dose of radiation will start with a low dose in the first group of patients. The dose of radiation will then proceed to successively higher doses of radiation for patient groups two, three and four, if it has been shown safe to do so. SIRT treatment uses SIR-Spheres microspheres, which are tiny beads about a third the width of a human hair that emit radiation that is designed to kill tumours. Millions of SIR-Spheres are injected by a specially trained doctor known as an Interventional Radiologist into the blood vessel(s) that supply blood to the tumours. After being injected into the blood vessels that supply the tumours, the SIR-Spheres lodge in the tiny blood vessels of the tumour, where they emit their radiation directly into the tumour, with the aim of destroying the tumour.

More than 50% of all Caucasian Australians will develop non-melanoma skin cancer (NMSC) during their lifetime, and more than one in 30 will develop melanoma. Ultraviolet radiation (UVR) from sunlight is the major cause of NMSC. In humans, both the ultraviolet A (UVA) and ultraviolet B (UVB) wavebands cause immunosuppression and DNA damage and therefore both UVA and UVB are likely to contribute to induction and development of NMSC. Broad-spectrum sunscreens, which filter both UVB and UVA can reduce UV immunosuppression, but sunscreens are generally much better at preventing sunburn than immunosuppression. As immunosuppression can occur with less than half the amount of UV needed to cause sunburn, the immune protection afforded by sunscreens “in the field” is likely to be low. Oral nicotinamide (vitamin B3) is available as an over-the-counter vitamin supplement and has been effective for over 50 years in the treatment of autoimmune and inflammatory skin disorders including bullous pemphigoid and rosacea. Unlike nicotinic acid, nicotinamide does not cause significant vasodilation or flushing and has few or no potential side effects. The most commonly used dose in autoimmune blistering disorders is 1500mg daily, with these patients often taking nicotinamide for several months. Adverse effects are exceptionally rare at these doses. In mice, nicotinamide reduces skin cancer numbers by 60% when applied as a 2.5% lotion. Our group has demonstrated that nicotinamide lotion completely prevents UV immunosuppression when applied in a double-blinded placebo-controlled manner to the backs of healthy human volunteers. We subsequently found that oral nicotinamide was also immune protective in healthy, Mantoux-positive volunteers, without adverse effects, at doses of either 500mg daily or 1500mg daily. Recently, we tested topical 1% nicotinamide on numbers of actinic keratoses, and found a significant reduction in numbers of keratoses at 3 months compared to placebo. We now plan to assess the effects of oral nicotinamide at an intermediate dose (500mg daily) on AK numbers. We hypothesise that nicotinamide will be well-tolerated, and could be used together with sunscreens to reduce UV immunosuppression and potentially treat or prevent actinic keratosis, premalignant lesions which act as a surrogate marker for squamous cell skin cancers.

Intensive care units (ICU) provide treatment and care to critically ill patients. Frequently, invasive monitoring and intrusive treatments delivered via artificial airways are required, which limit the ability to communicate. These factors, symptoms of illness and the busy environment may lead to discomfort, in particular the inability to sleep. The adverse health effects of poor quality sleep are understood and ICU patients are in greater need of sleep. Therefore, the aim of this study is to minimise sleep disruptions and improve the quality and quantity of ICU patients’ sleep. Thirty intensive care patients’ sleep has been measured using a portable sleep monitor. Simultaneous records were made of interruptions to the patients’ sleep and sound and light levels. The results from the first group have been discussed with ICU health care personnel who have decided which sleep promoting practices to implement, i.e. organisational and behavioural changes, such as blocks of uninterrupted time and noise reduction. Sleep data will be collected on a further thirty patients to assess the effectiveness of these interventions. No studies of this type have been conducted in Australian ICUs and few published studies have been performed with the purpose of improving sleep for ICU patients. This study is a unique opportunity to obtain data on ICU patients’ sleep in Australia using the most objective measure available, polysomnograph. It also has the potential to provide data on the effectiveness of sleep promoting activities.

The aim of this study is to evaluate the use of an internet guided education program for OCD. It is hypothesized that: 1. The treatment group will experience increased knowledge and understanding of OCD compared with baseline 2. The treatment group will show significant improvement on primary measures of OCD symptoms relative to baseline 3. Level of OCD severity will have no affect treatment response 5. The treatment will be deemed as acceptable by participants

Behaviours linked to better health outcomes for people with diabetes include regular blood glucose monitoring, appropriate insulin dosing, regulation of carbohydrate intake and increased physical activity. However, knowing what to do, and why, is often not enough to set-up and maintain the complex set of personal behaviours needed to improve health outcomes. This study examines the extent to which adding psychological intervention to usual medical care for young adults with type 1 diabetes can improve behavioural self-management of diabetes and associated health outcomes. Type 1 diabetics aged 18-25 years receiving regular outpatient multidisplinary care for their diabetes will be assigned to one of three conditions: (1) usual care alone; (2) behavioural self-management training based on the principles of applied behaviour analysis; and (3) stress-management training. Groups will be compared on behavioural adherence to diabetes self-management regimens, physiological health outcomes including metabolic control, and psychological wellbeing.

The aim of this study is to evaluate the effect of providing health professional students with the opportunity to observe and discuss a modelled role-play that demonstrates how to communicate evidence to patients and faciliate shared decision making. It is hypothesised that the intervention will be effective at improving students' ability to incorporate evidence into their communication and facilitate shared decision making with patients, and improve their confidence and attitude towards doing so.

BACKGROUND: Ectopic pregnancies are conceptuses that implant outside the womb, mainly the fallopian tube. They are life threatening since they can erode through major blood vessels causing fatal bleeding. While very small ectopic pregnancies can be treated medically (single injection of a chemotherapeutic agent ‘methotrexate’). The mainstay of treatment is surgery. We have undertaken 20 months of laboratory work to show placental tissue can be efficiently killed with the combination of two drugs: methotrexate and ‘gefitinib’. Gefitinib is an epidermal growth factor receptor (EGFR) inhibitor, never previously proposed to be used to treat ectopics. The EGFR pathway is used by the placenta an important survival signal. Thus using gefitinib to block EGFR activation can affect the viability of the ectopic pregnancy. Importantly, we have shown in preclinical studies that combining both drugs is supra-additive (i.e. the killing effects of adding both is stronger than the sum of each individual treatment). Importantly, the safety profile of each drug is known. Methotrexate is already used for small ectopic pregnancies where its toxicity profile is known. We plan using this exact same protocol that is used clinically (co-administered with gefitinib). Gefitinib is already used clinically in cancer treatment. After a primary lung cancer is treated, gefitinib tablets are taken once daily for life. It is thus not a traditional chemotherapeutic agent. It is well tolerated, but can cause a skin rash. Thus, we believe that combination treatment with methotrexate and gefitinib could be used to treat ectopic pregnancies. We now propose moving this idea into the clinic, starting phase I clinical trial toxicity studies. METHODS: The aim of this trial will be to determine whether a single injection of methotrexate and seven tablets of gefitinib is safe, and well tolerated. We propose recruiting 12 women presenting with a small stable ectopic pregnancy at Monash Medical Centre, Clayton. Treatment: Each participant will receive a single intramuscular injection of methotrexate (50mg/m2) on day 1, as per standard medical management of ectopic pregnancy. In addition, participants will receive one 250mg tablet of gefitinib daily for increasing amounts of time in subsequent cohorts: the first three women recruited (cohort one), will receive a single dose of 250mg gefitinib on day 1, the next three participants (cohort two), will receive three daily doses of 250mg gefitinib from day 1 to day 3. After review by the Human Research Ethics Committee (HREC) of an interim report on the first six participants and permission to proceed, the final six women recruited (cohort three), will receive seven daily doses of 250mg gefitinib orally from day 1 to day 7. Monitoring of toxicity: We will admit participants for up to seven days where they will be reviewed medically on a daily basis. Medical history and examination will be taken to monitor potential side effects (e.g. rash, diarrhoea, and respiratory symptoms). We will also look for any potential signs that the ectopic pregnancy has ruptured. If there are any such suspicions, we will offer prompt surgery. We will stop the medication if any significant side effects are noted. We will do regular blood tests to monitor potential toxicity to the renal, liver and haematological (blood) systems. Monitoring of treatment success: We will monitor human chorionic gonadotrophin (hCG) levels in the blood. This is a sensitive marker of placental cell mass. Thus, blood levels can tell clinicians whether the ectopic is disappearing (declining hCG levels). An hCG of zero would mean the women has been cured of their ectopic. Thus we will measure hCG regularly until it reaches zero. Expected outcome: Combination methotrexate and gefitinib is safe and well tolerated. We will generate critical toxicity data to justify a phase II trial to determine whether this proposed treatment can cure most ectopic pregnancies.

The purpose of this study is to test the hypothesis that by managing Emergency Department patients with uncomplicated cellulitis in a short stay unit with a continuous 24 hour infusion of 8g of intravenous flucloxacillin as opposed to the current standard treatment of four 2g intravenous blouses administered every six hours for 24 hours, significant nursing time and resources would be saved with there being no decrease in the clinical or microbiological cure rate of the cellulitis.

To compare the effects of a low GI diet versus a wholegrain diet during pregnancy in reducing prevalence of large for gestational age infants in women at high risk for developing gestational diabetes. The study hypothesis is that infants born to high risk pregnant women who received low GI dietary advice will have a lower birth weight z-score and percentage body fat than those whose mothers received advice on a macronutrient-matched wholegrain diet.