ANZCTR search results

The aim of this study is to determine the maximum safe and effective dose of a novel therapeutic ADVC001 complexed with the radio-isotope alpha-212 ([212Pb]Pb-ADVC001) for the treatment of metastatic prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of metastatic adenocarcinoma of the prostate, and have received at least one cycle of androgen receptor therapy and exposure to a taxane-based chemotherapy. Study details All participants will receive treatment with four cycles of [212Pb]Pb-ADVC001. The intervention will be administered intravenously on day 1 during each 6-week cycle. Participants will be monitored for any adverse events for up to 36 weeks after commencing therapy, and will undergo imaging and blood tests for the duration of treatment to determine their response to therapy. Participants will also have blood samples collected to determine how the study drug is metabolised by the body. It is hoped that this study may help to determine the maximum dose at which [212Pb]Pb-ADVC001 is both safe and effective for the treatment of metastatic prostate cancer. This may help to direct how this novel treatment is used for individuals with metastatic prostate cancer in future.

The goal of our study is to assess the effects of increasing left ventricular assist device speed (an artificial heart pump) and intravenous GTN (a medications that dilates the vessels) on exercise capacity. We will also assess the effect of these interventions on the pressures inside the heart and the amount of blood pumped by the LVAD (cardiac output), using an intracardiac catheter and cardiac ultrasound (echocardiography). Blood tests will also be taken during the study for additional information. Patients will perform the exercise protocol on a stationary bike while lying down. Our main hypothesis is that both pump speed increase and intravenous GTN will lead to lower cardiac pressures and vessel dilatation, maximising cardiac output and exercise capacity.

Multifocal contact lenses (MFCLs) have shown promising results in slowing myopia progression in children. However, the underlying mechanism for treating myopia with MFCLs is still uncertain; it is assumed that MFCLs reduce hyperopic defocus in the periphery, inhibit accommodation lag, and improve the amplitude of accommodation in myopes. It has been demonstrated that myopic blur induced by the peripheral portions of these lenses can reduce myopia progression in children by 36.4% and axial elongation by 37.9%. However, the effect of MFCL on the ability of the eye to detect the stimulus properties such as contrast, colour, and motion remains unknown, and it is possible that MFCL impact these functions, which may contribute to its effect in slowing myopia progression. It is assumed that both optical and pharmaceutical treatments use two different mechanisms to reduce myopia progression and combining both interventions (known as combined therapy) may provide better myopia control than one treatment alone (monotherapy). The primary objective of this study is to examine the effects of MFCL alone (monotherapy) and its combination with 0.05 % atropine sulfate eye drops (combined therapy) on a range of basic visual functions (contrast sensitivity, colour, and motion detection), pupil size, and image quality. This research is expected to provide a greater understanding of the effect of MFCL on the blur detection mechanism of the eye and associated visual function changes and the potential mechanisms underlying myopia development and progression. To achieve this, the outcome measurements will be taken twice, first with MiSight contact lenses and then with 0.05 % atropine.

Topical atropine is a cycloplegic (reduces or temporarily eliminates focusing ability) and mydriatic (increases pupil size) agent that has shown promising results in slowing myopia (nearsightedness) progression in children in a dose-dependent manner. However, the exact mechanism of topical atropine slowing myopia is still unclear. Atropine is known to reduce the focusing ability and increase the pupil size of the eye; however, the effect of atropine on the ability of the eye to detect the stimulus properties such as contrast, colour, and motion remains unknown, and it is possible that atropine impact these functions, which may contribute to its effect in slowing myopia progression. The primary objective of this study is to examine the impact of 0.05 % atropine sulfate eye drops for approximately 2 hours on a range of basic visual functions (contrast sensitivity, colour, and motion detection), pupil size, and image quality. This research is expected to provide a greater understanding of the effect of 0.05 % atropine on the blur detection mechanism of the eye and associated visual function changes and the potential mechanisms underlying myopia development and progression. To achieve this, 0.05 % atropine will be applied to the participant's eye, and the outcome measurements will be taken.

This study will assess the feasibility of delivering a novel remotely monitored, dose measured cycling exercise rehabilitation program to patients following total knee arthroplasty (TKA). This new method uses a mobile cycling device with an in-built power meter remotely monitored by clinicians to prescribe and modify the post-operative exercise regimen, tailoring it specifically to the patient. The feasibility outcomes from this study will inform the acceptability and efficacy of a post-operative cycling exercise program and a larger randomised controlled trial on knee muscle strength, function and post-operative recovery outcomes of a cycling based protocol versus a standard exercise regimen post TKA.

The purpose of this study is to examine if a window of 7 to 21 days between radiotherapy and surgery is feasible for metastatic brain cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with non-small cell lung cancer (NSCLC) or melanoma, and have confirmed metastatic brain cancer. Study details All participants in this study will undergo radiation therapy to individual brain tumours. This will be performed as per standard clinical practice, and involves 1-5 outpatient visits to the Peter MacCallum Cancer Centre for treatment. In general, each treatment will take approximately 30 minutes. Blood tests will be performed before radiation therapy, and at 1 week, 4 weeks, and 3 months after radiation therapy. These blood tests will coincide with follow-up appointments with a doctor. After radiation therapy is completed, 7-21 days later there will be surgery to remove the radiation-treated brain tumours. The surgery will be performed as per standard clinical practice at the Royal Melbourne Hospital. There will be a few days of hospital stay after the surgery. Brain cancer tissue from surgery will be collected for this study. It is hoped that this research will reveal if having a window of 7 to 21 days between radiation therapy and surgery for brain cancers is beneficial, and lead to better outcomes for cancer patients.

Diabetes related foot ulcers are a condition with significant financial and physical burden. New guidelines highlight a concerning lack of evidence related to the role of exercise in the management of this condition and that, given the well-known benefits of participation in exercise, it should be considered an important area of future research. However, there may be a number of physical and psychological barriers which prevent patients participating in physical activity and exercise, particularly when admitted to hospital. This project aims to explore and describe current barriers to activity and exercise in this patient group. We will also investigate the feasibility and safety of prescribing an exercise programme to patients who are admitted to hospital with diabetes related foot ulcers.

Dysphagia is common in adults living in Residential Aged Care Homes (RACHs). It can lead to malnutrition, dehydration, reduced quality of life, aspiration pneumonia, choking and death. Timely instrumental swallowing assessment, specifically Flexible Endoscopic Evaluation of Swallowing (FEES), can help to minimise these complications. Adults living in RACHs in Australia do not have equitable access to FEES compared to older adults living in other settings. This study explored a mobile service model to increase older adults access to FEES. The hypothesis was that portable FEES delivered onsite in RACHs is a safe, well-tolerated, and practical service model that can increase access to timely, person-centered, high quality swallowing care.

The purpose of this study is to see if virtual reality immersion therapy can be further tested as a potential therapy for alleviating symptoms in palliative care patients while in hospital. The information obtained will help us to learn strategies, such as time and frequency of usage of therapy, to potentially help many patients in the future. Study participation: Participants will undergo virtual reality immersion sessions daily while in hospital. Twice daily symptom assessments will be done by the investigating team. Follow up questionnaire will be applied at day 3 since commencement of intervention (after discharge if that happens sooner). A small control group will also have symptoms assessments done twice daily. Symptom assessments: Participants will answer verbally a questionnaire grading symptoms from 0 to 10, which will happen twice daily. These will last between 5 to 20 minutes. From day 3 of participating, each participant will be asked, only once, questions related to their experience up until then including tolerability and the device and duration of therapy. This questionnaire will last 10 to 30 minutes. Risks and side effects of the therapy are uncommon, but include dizziness, vertigo nausea, vomiting, anxiety and discomfort. The benefits might include symptom improvement, but will certainly help us learning more about this possibly helpful therapy.

Australian data shows that 20-25% of newly diagnosed myeloma patients who are treated with standard of care relapse within the first 12 months of starting treatment and their survival rate is lower than that of patients who relapse after 12 months of starting treatment. This group of patients are deemed to be at ‘high-risk’. The purpose of this study is to optimise treatment of newly diagnosed multiple myeloma (MM) patients who undergo autologous stem cell treatment (ASCT) by using diagnostic techniques to guide whether selinexor should be added to standard care, whether it is and beneficial to do so. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been recently diagnosed with multiple myeloma. If must meet additional heart, liver and kidney health criteria prior to commencing treatment. [Study details] All participants who choose to enrol in this study will have a bone marrow sample taken and assessed to determine whether they are at high risk or standard risk disease. These details will then be used to allocate participants for ‘induction’ therapy, to either standard of care treatment (consisting of bortezomib, lenalidomide and dexamethasone), or standard of care treatment with added selinexor. This is a risk-adaptive approach to treatment, meaning your treatment is guided by the results of your myeloma risk profile. Participants will continue with their allocated treatments for 4-5 months. After this time, all participants will then undergo preparation for an autologous stem cell transplant, where healthy stem cells will be harvested from each participant and expanded externally, before being re-implanted back to stimulate further stem cell growth. At 5-6 months after the transplant, all participants will be required to provide a second bone marrow sample to undergo a second test to check how they are responding to treatment and assess if there is a very small but detectable number of myeloma cells. For standard risk patients, if there isn’t any detectable myeloma cells, you will continue treatment with only lenalidomide. If there are detectable cells, you will be given lenalidomide and selinexor. High-risk patients will be given lenalidomide and selinexor regardless of the results. This is called 'maintenance' therapy. Participants will then continue taking their second allocation of medications for maintenance for until the treatments are no longer effective. This could range from months to years. Further bone marrow samples will be required at 6 and 12 months after commencing maintenance treatment to test for detectable myeloma cells. The trial is intended to run over 4-5 years. You will be asked to complete short questionnaires about your multiple myeloma treatment and your health-related quality of life every month prior to the transplant, about 4-5 months after transplant and within 12 months after commencing maintenance therapy.