ANZCTR search results

The purpose of this study is to test the idea of a new way of using an old drug in men with prostate cancer that has spread. Who is it for? You may be eligible for this study if you have advanced prostate cancer and are eligible to take a medicine called enzalutamide/Xtandi. Study details If a man taking enzalutamide chooses to take part in the study, their oncologist will advise them to pause taking their medication if their PSA blood test falls by over half. If their PSA blood test returns to pre-treatment levels, participants will then be advised to recommence taking the tablets again until again, the PSA blood test has decreased by more than 50%. The idea is to take breaks from the hormone tablets, using them for long enough to control the cancer, but then stopping and saving them up until later to treat the cancer again. The blood tests, scans, and doctors appointments in the trial are almost identical to normal treatments; men on the trial will be asked to complete short questionnaires, and have an extra blood test every three months. It is hoped this study will demonstrate this strategy of treatment will reduce side-effects, and may improve the lives and survival of men with prostate cancer.

Oxaliplatin chemotherapy improves survival but causes acute neuropathy (paraesthesias or dysesthesias) and chronic chemotherapy-induced peripheral neuropathy (CIPN) in almost all patients. CIPN can last for months to years, and can have a major impact on quality of life. It is suggested that ibudilast can prevent and treat this neurotoxicity. The purpose of this study is to determine if ibudilast can safely and effectively decrease neurotoxicity in patients receiving chemotherapy. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic colorectal cancer, and will be commencing chemotherapy with oxaliplatin. Study details Participants in this study will continue with their prescribed chemotherapy. As part of this study, participants will be randomly allocated to one of two groups: 1. Ibudilast taken twice a day for the duration of oxaliplatin, and 2. Placebo capsules, taken twice a day for the same period. Participants will complete questionnaires and be examined by their usual oncologist. Results of usual blood tests and imaging will be reviewed. It is hoped that this research will help determine if ibudilast can be effective in reducing neurotoxicity in participants. If it is shown to be effective, it may allow more chemotherapy to be delivered, and therefore may improve survival rates in people with colorectal cancer.

We want to determine the effect of regular exercise on cognitive functioning in young adults with Down syndrome. We will compare the effect of a 12-­week exercise intervention on cognitive function against a wait list control group. Participants will complete a weight training program with a mentor to assist them, at a local gym. Exercise sessions will run for one hour, twice a week for 12 weeks. We will recruit a 30 participants aged 15-35 years old with Down syndrome. Baseline data on Executive functioning, Short ­term Memory, Information processing speed and Intellectual ability will be collected at baseline (week 0). Executive functioning, Short ­term Memory and Information processing speed will be measured again during follow­-up (week 13) after having either completed the exercise program or doing their usual activities. We will also collect data on participant demographics.

Primary ciliary dyskinesia (PCD), is a rare, incurable, progressive, serious disorder with a large unmet need in both the diagnosis & treatment. We will test the benefits of a currently used (but unapproved for long term use in PCD) antibiotic (azithromycin) and a novel mucolytic (erdosteine). We plan a parallel, multicentre, double-blinded, double-dummy RCT. Our primary question is: Among children and adults with PCD, does azithromycin or erdosteine reduce acute respiratory exacerbations during 12-mo of treatment? Study sites are Sydney, Brisbane, Melbourne, Darwin, Perth. Our secondary aims are to: 2. Determine the effects of 12-months of the azithromycin or erdosteine on PCD-quality of life (QoL), its cost effectiveness and impact on bacterial type and antibiotic resistance 3. Assess whether whole exome sequencing (WES) can identify known and unknown gene mutations in PCD, and whether knowing this improves the patient's journey

The overall goal of this project is to increase the detection and referral of NAFLD patients with advanced hepatic fibrosis and cirrhosis to the Gastroenterology Departments at the Princess Alexandra and Logan Hospitals and to reduce the number of unnecessary referrals to these specialist outpatient clinics. Referrals to secondary care and evaluation of the outcomes of referrals after introduction of the integrated NAFLD pathway will be performed. Calculation of the costs and potential healthcare savings of the NAFLD pathway in comparison with standard care will be undertaken.

The purpose of this research is to investigate the effects of a rice bran arabinoxylan compound (RBAC) as a nutritional supplement on the health-related quality of life (QoL) of cancer patients. Who is it for? You may be eligible for this study if you are between 18 and 70 years old, diagnosed with any solid organ cancer, and currently undergoing active treatment. Study details Participants in this study will be randomised by chance into two groups. One group will consume 3g per day of the study compound (RBAC) packed in sachets for 24 weeks. The other group will take an inactive placebo treatment for the same period. The assigned intervention will be in addition to your usual cancer care. As part of the study, all participants will complete questionnaires, be weighed and provide blood and stool samples. Results from this research can improve the understanding of the effect of RBAC during cancer treatment, inform the planning of a larger trial, and supply data to validate the immuno-therapeutic benefits of RBAC.

This study aims to determine whether dietary supplementation with L-serine improves clinical effects of hereditary sensory neuropathy type 1 (HSN1). The most prevalent form of HSN1 is caused by variations (mutations) in the serine palmitoyltransferase (SPT) gene. Deoxysphingolipid bases are toxic by-products produced by mutations in the SPT gene. In a rat model of HSN1, dietary supplementation with the amino acid, L-serine, reduced levels of deoxysphingolipid bases (Garofalo K, Penno A, Schmidt BP, et al. Oral L-serine supplementation reduces production of neurotoxic deoxysphingolipids in mice and humans with hereditary sensory autonomic neuropathy type 1. J Clin Invest 2011;121:4735-4745). Serine treatment may prevent the clinical accompaniments of this disease which include sensory loss, insensitivity to pain and varying degrees of muscle weakness and wasting. Frequent complications in HSN1 are foot ulceration's, infections and limb amputations. We wish to determine the power of various modalities of testing (skin sensitivity testing, skin biopsy and standard clinical and neurophysiology measures) for a larger trial.

Periodontitis, especially stage III and IV, grade C periodontitis carries significant chances of tooth loss. Adjunctive systemic antimicrobials may provide additional benefits in these patients, however, the evidence is unclear. If the adjunctive antimicrobial has additional anti-inflammatory properties it may help in the modulation of the host response. Azithromycin is one such antimicrobial with additional host-modulating properties. Although the anti-microbial properties of azithromycin have been studied extensively, there are few studies on its host-modulating properties in periodontitis. It is hypothesized that adjunctive administration of azithromycin will result in decreased periodontal inflamed surface area scores, gain in clinical attachment level, reduced pocket depth, decreased levels of pro-inflammatory cytokines in the gingival crevicular fluid & saliva and decrease in the number of pathogenic bacteria in the periodontal pockets.

The proposed project will evaluate the feasibility, acceptability and preliminary effectiveness of a telephone delivered intervention that targets problematic alcohol consumption in young people living with severe mental ill-health (SMI). Analysis will focus on issues associated with recruitment, ongoing engagement of participants, and satisfaction with the intervention. We will also examine changes in alcohol consumption and mental health symptomatology at follow-up. The randomised pilot trial compares the effects of two interventions: Quik Fix (2 session brief intervention) vs a 10 session Transdiagnostic CBT (TrCBT) intervention. Additional goals include • increasing the identification of young Australians experiencing comorbid SMI and hazardous alcohol use; • providing greater access to evidence-based treatments;

Right hepatectomy involves removal of a significant amount of liver parenchymal tissue and a lot of planning is required to ensure avoiding the inherent risks of major haemorrhage and severe hypotension. Over the last two decades, there have been the development of Enhanced Recovery After Surgery (ERAS) programmes particular for liver resections, aimed at reducing overall morbidity and length of hospital stay. . The traditional approach at Austin health focuses on “restrictive” fluid therapy, guided by “low central venous pressure anaesthesia” during liver resections. A second approach has been developed, which uses a surgery-specific cardiac output-guided algorithm for patients undergoing complex liver resection. This algorithm has been modified from another algorithm that has been used for pancreatic surgery. The aim of the study is to evaluate the two fluid intervention strategies and their differences in the use of intraoperative fluid, vasoactive medications, post-operative complications and hospital length of stay. This is a retrospective observational study that looked at patients undergoing major right hepatectomy with usual care or “traditional” restrictive fluid therapy & low CVP anaesthesia, compared to those who were managed with the surgery-specific cardiac output algorithm. It is hypothesised that the surgery-specific cardiac output-guided algorithm improves length of hospital stay and reduces morbidity and post-operative complications in major right hepatectomy.