ANZCTR search results

The study will compare the effectiveness of standard deprivation therapy and radiation therapy combined either with enzalutamide or with currently available antiandrogen drugs for improving the survival in men with localised prostate cancer at high risk of recurrence. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more who has been diagnosed with adenocarcinoma of the prostate, judged to be at high risk for recurrence. You must also be deemed suitable for external beam radiation therapy. Study details Participants in this study will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will be treated with 160mg Enzalutamide daily by mouth for 24 months. Participants in the other group will receive currently available anti-androgen drugs for 6 months. Anti-androgen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called “androgen receptors.” Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Participants will be regularly assessed in order to determine which of these treatments is best at improving the survival of men, as well as the ability of treatments to control prostate cancer, the safety of the treatments, the effects of the treatments on quality of life, and differences in the costs of care.

The PMH physiotherapy and plastics department would like to review the current practices of how we manage children with the simpler, uncomplicated finger fractures (broken bones). We want to see if we can provide treatment in a more time efficient and cost effective way, whilst ensuring the fractures continue to heal well. These fractures tend to managed with a 3 week immobilisation in a plaster cast. Currently, after seeing the doctor and having the cast removed, families and patients may wait over two hours to see the physiotherapists for advice on exercise and a home program to help with the stiffness after the cast is taken off. This long wait to see the physiotherapy continues despite many changes made to the way we run the clinics in an attempt to decrease this wait time. Many families have complained about this long wait time. We have investigated how other children’s hospitals in Australia manage simple fractures of the hand. We found that the treatment varies between the Australian states and there is little in the medical literature that gives us guidance as to whether children have any short or long term problems if they don’t have physiotherapy after the cast is taken off. We want to determine if children with simple hand fractures are able to achieve full active movement of all the fingers and wrist with just the provision of an education and physiotherapy exercise handout alone, instead of the one-on-one hand therapy currently provided by the physiotherapist. This in turn will reduce the burden on the family to travel to PMH for unnecessary appointments and decrease the wait time for physiotherapy, as fewer children will need this service during clinic. It will also ensure the physiotherapist can safely prioritise patients with other more complicated fractures where physiotherapy is essential to improve their recovery. The outcome of this study will identify the most efficient and effective way of managing the simple finger and hand fractures. Other Australian states are interested in changing their practise based on our results.

This project builds on an earlier project and seeks to examine the efficacy and acceptability of the Wellbeing Course for Arabs. We expect overall the Course that symptoms of anxiety and depression will improve in the culturally-adapted group. However, we expect that the participants who are more acculturated will do better in the culturally adapted version of the Wellbeing Course.

In this study, we will address the following specific research question: can a single-dose of tocilizumab prevent allergen-induced airway inflammation and bronchoconstriction? Tocilizumab will be administered intravenously as a single dose of 8mg/kg seven days before allergen challenge. This combination of dose and route of administration is currently approved in Australia to treat patients with rheumatoid arthritis monthly. Lung function will be assessed periodically in the 7h following allergen challenge. Airway inflammation will be measured at 7h and 24h following allergen challenge. Bronchoconstriction and airway inflammation will be compared between the TCZ and placebo groups to determine drug efficacy.

Auditory hallucinations (AH) are one of the most common and distressing symptoms of schizophrenia, occurring in more than 70% of patients. Whilst the primary form of treatment for AH is antipsychotic medications, a significant proportion (30-40%) of patients fail to respond significantly to pharmacological therapy. Novel treatment options are therefore needed. A substantial body of evidence suggests that auditory hallucinations may be improved with repetitive Transcranial Magnetic Stimulation (rTMS), although in these studies, and in our clinical experience, only a small proportion of patients respond to this treatment. The majority of studies which have demonstrated modest response rates to rTMS for AH have used a relatively standard approach for targeting the brain regions believed to be implicated in AH; namely, the 10–20 EEG system for localising the left temporoparietal cortex. It is therefore reasonable to propose that by more accurately targeting brain regions implicated in AH for each individual patient, a greater reduction in the intensity and frequency of AH may be observed. We propose to investigate this using neuro-navigational methods combined with resting state functional connectivity MRI-based scanning to more precisely pinpoint the site of stimulation in individual patients. We will recruit participants with a diagnosis with schizophrenia or schizoaffective disorder who experience auditory hallucinations, and they will undergo a resting state MRI scan prior to treatment. They will then receive rTMS treatment either based on an analysis of their MRI scan, or treatment localised using the standard 10-20 EEG method. This study has the potential to substantially contribute to the development of rTMS as a new therapeutic tool for treatment-resistant auditory hallucinations.

Dystonia is a movement disorder characterised by involuntary twisting movements and abnormal postures of the body. Cervical dystonia is the most common focal dystonia of younger adults, producing abnormal neck postures, twisting, shaking and turning movements of the neck, and pain in the neck and shoulders. How dystonia develops is not known. Treatment for cervical dystonia is predominantly with Botulinum toxin. There is compelling evidence for its benefit in reducing symptoms of head posturing and pain, however it requires repeated injections and does not always provide satisfactory outcomes. Botulinum toxin is known to interrupt neuro-muscular interaction, producing focal muscle weakness, however evidence for its use in migraine headache has implicated a direct effect on pain perception. Whether improvement in dystonia with botulinum toxin is related only to motor effects or has a longer term benefit on modulating the dystonia itself is not known. The experience of pain can alter sensory and motor processing related to direct interference with neuroplastic processes or compromised motor performance. Sensory testing has shown decreased sensory function in the affected compared with unaffected hand in people with hand dystonia. This type of sensory testing has not been performed in people with cervical dystonia. It is likely all dystonia arises from abnormal sensorimotor integration processes, though this process is currently incompletely understood. This project aims to measure peripheral sensory perception objectively in patients with cervical dystonia to determine if their sensation is abnormal, if this is a generalised or focal situation, and to determine if this sensation is altered by the administration of botulinum toxin which is effective in reducing the severity of the movements.

This study is evaluating the safety of a fluorescent marker (BLZ-100) used to visualise cancer cells in adults with skin cancer. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with non-melanotic skin cancer (e.g. non metastatic basal cell or squamous cell carcinomas or amelanotic melanoma) and are scheduled for surgical excision. Many types of cancer are primarily treated with surgery and the extent of surgical removal of the tumour is directly related to patient survival. However, it is often difficult for surgeons to distinguish tumour tissue from normal tissue or to detect tumour cells that have spread from the original tumour site. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumour to prevent adverse effects on function. In this study all participants will be administered BLZ-100 intravenously (i.e. directly into the vein) approximately 48 hours before scheduled excision of cancer lesions. BLZ-100 is a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer cells to facilitate surgical resection. We hope that BLZ-100 will improve surgical outcomes by allowing surgeons to visualise the edges of the tumour and small groups of cancer cells in real-time, as they operate.

A combined palliative and nephrology, Renal Supportive Care clinic was established in March 2009. This research aims to describe the impact of a specialised palliative nephrology service on outcomes and will put this in context by also describing outcomes of patients who are managed in standard renal clinics (pre-dialysis clinic). The data collected is collected as part of standard medical care.

This research project is aimed at developing and assessing the feasibility and acceptability of an online program for men who have undergone treatment for testicular cancer. The program has been designed to reduce distress and address the needs of these men. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more who has completed treatment for testicular cancer between 6 months to 5 years ago, and have no evidence of disease recurrence. You will need to have access to computer at least weekly for up to 10 weeks. Study details All participants in this study will receive an online intervention to address the specific unmet needs of testicular cancer survivors (such as for help with fear of cancer recurrence, body image and sexual issues, financial issues and re-establishing a sense of normal), as well as general anxiety and depression.The intervention involves completion of 6 online modules in 10 weeks. On completion of the intervention at 10 weeks, participants will be asked to complete a number of questionnaires about the feasibility, acceptability, utility, comprehensiveness, relevance, helpfulness, and simplicity of the intervention.

Participants are invited to take part in this research study to test a new treatment combination for prostate cancer. This is because they have cancer that started in the prostate and has spread to other parts of their body. This is known as metastatic prostate cancer. Current treatment for newly diagnosed metastatic prostate cancer involves androgen deprivation therapy(ADT). Androgen deprivation therapy has two components: 1. The main component is by stopping the release of androgen from the testicles. This is mainly done by using drugs that prevent the testicles from making androgens, and therefore reducing the levels of androgens in the body to low levels. These drugs are called luteinising hormone releasing hormone analogues (LHRHA). These drugs are given as injections. This is usually part of the standard initial treatment for men in your situation. The other way of reducing androgen production by the testicles is with a surgical operation to remove both testicles. This is not part of the trial. If participants have already had this surgical procedure or it is planned to be done, they will not need to be on LHRHA, but can still take part in this study. 2. The second component of ADT is to block the effects of androgens produced in other parts of the body with antiandrogen drugs. Antiandrogen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called 'androgen receptors'. Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Several different types of antiandrogen drugs are available for use already. Enzalutamide is a new antiandrogen that is not yet approved for use in Australia. This study will compare the effectiveness of enzalutamide versus the currently available antiandrogen drugs when used on a background of treatment with a LHRHA (or surgical removal of the testicles). The main aim of the study is to see which of these combinations is best at improving the survival of men in this situation. Recent studies show promising results with the use of enzalutamide in participants who had been treated with androgen deprivation therapy and were no longer responding to the standard antiandrogens, this is known as castrate resistant prostate cancer (CRPC), which is a more advanced stage than the type of metastatic prostate cancer being studied here. With this stage of metastatic prostate cancer there is no evidence yet on which treatment is best to treat it. To do this, a total of 1100 participants will participate where half the participants on the study will receive enzalutamide with a LHRHA or surgical operation to remove both testicles and the other half (550 participants) will receive already available antiandrogens (but not enzalutamide) with a LHRHA or surgical operation to remove testicles. All participants on this study will receive active therapy and no placebo treatment will be used. The study is open label, meaning that both the participants and the investigators will know the treatment the participant will receive.