ANZCTR search results

Cancer immunotherapy with immune checkpoint inhibitors (ICI) have revolutionised the treatment and outcomes for multiple cancers in the past 10 years leading to sustained remission and cure in some patients even when diagnosed with advanced disease. However, immune mediated side effects are common including diarrhoea and colitis which can affect up to 40% of patients who take ICI's. This study aims to assess whether a short course (7 days) of oral treatment with faecal microbiota transplantation (FMT) therapy has any impact upon ICI colitis symptoms in patients who are affected by this. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have experienced diarrhoea from your ICI and your last dose was within 4 months of symptom onset. Participants who are steroid intolerant, have had no response to oral glucocorticoids, have had recurrence of symptoms during or following corticosteroid wean or have had recurrent episodes of immune checkpoint inhibitor colitis will be considered for inclusion. Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the FMT group or a placebo group. Both groups will be asked to take FMT capsules each day for 7 days, and to keep a diary of their bowel movements for up to 12 weeks after enrolling in the study. Participants will also be asked to provide stool and blood samples throughout the study and may also require a colonoscopy. The overall participation will be 12 weeks. It is hoped this research will demonstrate that it is safe and effective to use orally administered FMT to treat ICI colitis in cancer patients who have been taking immune checkpoint inhibitors. If FMT is successful, this may lead to a reduction in overall corticosteroid use, hospitalisation and an early resumption of their cancer immunotherapy for affected patients.

Cancer therapies are associated with significant adverse events, particularly cognitive impairment, where over 75% of breast cancer patients report cognitive impairment. As breast cancer occurs primarily in mid-life, this has created a large population of survivors who are at a unique intersection of both cancer and age-related effects on the brain, specifically declined brain blood vessel function and cognition. The aim of this study is to investigate the effects of a supervised 8-week multimodal exercise intervention on brain blood vessel and cognitive function in female breast cancer patients. Who is it for? You may be eligible for this study if you are a female breast cancer patient aged 40-80 years and you meet specific health requirements (blood pressure, heart health and cognitive/mental function). Study details Participants who choose to enrol in this study who are willing to undertake the exercise intervention program will be asked to complete a series of baseline measurements, before being invited to attend 2-3 x 1 hour exercise sessions each week for 8 weeks. Each sessions will include both aerobic exercises (e.g. stationary cycling, rowing) and muscle strength training (e.g. chest press and lat pulldown) and will be supervised by an Accredited Exercise Physiologist. One week after the completion of the exercise program, participants will be asked to complete the baseline measurements again for comparison. A second group of participants who are not wishing to participate in exercise at this point in time will also be invited to complete both the baseline and 9 week measurements for comparison. These participants will form the control group. Once the study has concluded, the control group will be provided with the exercise regime used in this study It is hoped this research will provide some evidence as to the effects of exercise therapy on cardiovascular, cerebrovascular and cognitive function in breast cancer patients. If this study is found to have a positive impact on the cardiovascular health and cerebrovascular and cognitive functions of these patients it may evolve into a larger randomised controlled trial to further examine the exercise effects in this population.

This is the first pragmatic randomised trial to comparatively investigate Ethanol ablation and Radiofrequency ablation for the treatment of chronic Morton’s neuroma. This study was deemed necessary as no prospective studies compare Ethanol ablation with Radiofrequency ablation or focus on patient recorded outcome measures, specifically measuring pain, foot health, function and ability.

Decline in cognition and physical function often occurs simultaneously and increase falls risk in older people. Previous research has shown that step training reduces falls risk as well as improving cognition. Previous research has also shown that combining motor and cognitive training would induce greater cognitive improvements than individual motor or cognitive training. Therefore, we have created ReacStep, a novel step training program with an added cognitive component. it requires minimal equipment and can be individually tailored to older adults with a range of physical functional levels. This trial will examine the effects of the ReacStep program on fall risk and cognitive function in older adults. We hypothesise the the ReacStep program will improve fall risk and cognition in healthy older adults. If this study is successful at improving fall risk and cognition, it will provide a basis for a larger clinical trial and a feasible solution for preventing falls and dementia in older adults, and can be a new training program that health professionals can use in their practice.

This study aims to build on existing local research to trial a linguistically and culturally tailored asthma education strategy that builds on our recently established early intervention asthma nurse lead education program. Shortly following a hospital admission, patients with asthma including those from culturally and linguistically diverse communities will be seen by a Nurse educator and a Bilingual health care worker if required for a detailed asthma education session. They will be supported by phone and in person over the next few months. Their asthma control will be assessed with a validated questionnaire at the end of the study. We hope to demonstrate that such a tailor-made programme of asthma education will improve asthma outcomes. for all patients with asthma

Premenstrual dysphoric disorder (PMDD) is a severe, cyclical depressive disorder that affects 2-8% of women of reproductive age. Previously known as late luteal phase dysphoric disorder, PMDD is characterised by irritability, mood changes/swings and physical symptoms of that develop during the luteal phase of the menstrual cycle and resolve after the commencement of menses. PMDD carries significant distress and morbidity, for which limited therapeutic options exist. The urgent and clear need exists for effective and harmless treatments in PMDD. The scope exists to investigate novel therapeutic modalities for this crippling disorder for many. The proposed project meets this need by investigating the efficacy of application of Theta Burst Stimulation (TBS) in PMDD in the form of a pilot study. Transcranial Magnetic Stimulation (TMS) is a non-invasive means of stimulating nerve cells in superficial areas of the brain. TBS (a patterned form of TMS) has been approved by the FDA as a treatment for treatment-resistant major depression. TBS has received minimal research attention as a potential treatment for PMDD. The research project aims to evaluate if theta burst stimulation (TBS) is effective in treating mood and other psychological symptoms in PMDD.

Huntington’s disease (HD) involves progressive decline in cognitive function, often beginning many years prior to clinical diagnosis, and drastically affects quality of life. Further, there are currently no effective treatments for cognitive decline in HD. Cognitive training has been found to be effective in improving cognitive function in other populations, but has not been thoroughly investigated in HD. This study aims to examine the effects of cognitive training on cognitive and clinical outcomes in people with HD, as well as its effects on brain function. This will be done by randomly allocating participants to either an intervention group or a control group. The intervention group will complete cognitive training over 3 months, whereas the control group will receive a monthly newsletter on lifestyle factors associated with cognitive function and will be provided access to the training program after the study period. It is hypothesised that compared to the control group, participants in the intervention group will have: (1) improved cognitive function; (2) improved neuropsychiatric symptoms; (3) improved subjective cognition; (4) improved health-related quality of life; (5) increased connectivity in brain networks involved in cognitive tasks; and (6) increased connectivity in brain networks during rest, after the study period.

Previous research indicates that text-message based programmes can be an effective public health approach to improve adolescent health behaviours, including tobacco use, thus may have promise as an approach to influence adolescent e-cigarette behaviours. We aim to conduct a randomised controlled trial to examine the potential effect of a text-message program targeting parents to prevent adolescent e-cigarette use. Over 12 weeks, parents of adolescents will receive text messages designed to address the factors identified that increase the risk of adolescent use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey.

The National Comprehensive Cancer Network now recommends molecular screening for all patients with advanced pancreatic duct adenocarcinoma (PDAC) to enable patients to benefit from these strategies. The predominant method of obtaining tissue to establish the diagnosis of PDAC is a specific ultrasound guided fine needle biopsy. This study aims to test the use of additional fluids that are collected as part of the tissue biopsy to determine whether the DNA extracted from these fluids is enough to create a genetic profile of the patient's pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with pancreatic adenocarcinoma that is locally advanced or metastatic (has spread to other body systems) and you have undergone an endoscopic ultrasound biopsy to establish the diagnosis of pancreatic cancer. Study details All participants who choose to enrol in this study will consent to having the fluids previously collected during their ultrasound biopsy assessed. Participants will not be asked to provide additional blood or tissue samples as part of this study. Each sample will be assessed to determine whether there is sufficient genetic material present to create a profile of the patient's specific cancer. For participants where a genetic profile can be generated, this information will be sent to a board of cancer experts who will review the profile against a list of new and existing cancer treatments. If a suitable treatment is identified, the participant will be informed within 1 month following review of their comprehensive molecular profiling, and they will then be able to start on the treatment if they agree to. It is hoped this research will demonstrate that it is possible to create a specific cancer profile for patients with pancreatic cancer from previously collected samples, without the need for additional biopsies. It is also hoped that this research may enable identification of personalised treatment options for pancreatic cancer patients, which may improve their quality of life and survival.

It is hypothesised that implantation of the ReActiv8 System will lead to a reduction in pain and/or disability for participants with CLBP, prior decompressive surgery (discectomy or laminectomy), with unsatisfactory pain relief despite continuing medical management (including physical therapy and medications). This Investigator-Initiated Study will be a single arm prospective study using two cohorts. Cohort 1 will be 30 patients who have mechanical LBP for > or equal to 12 months following a discectomy procedure, and Cohort 2 will be 30 patients who have had chronic LBP > or equal to 12 months following a lumbar laminectomy. The study will consist of up to 60 patients implanted with ReActiv8, who are indicated for participation in this study.