ANZCTR search results

This study will investigate the safety, tolerability, and pharmacokinetics (a measure of how the human body processes a substance) of different doses of OP-1250, a new drug that acts to block oestrogen hormone receptors, in combination with palbociclib (an established anti-cancer drug) in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, and you don't have any known heart conditions including heart disease or irregular heartbeat (arrhythmia). Study details There are two stages to this study: Part 1) Dose exploration stage where up to 6 different oral doses of OP-1250 will be used to determine the maximum tolerated dose for OP-1250 in participants with breast cancer. Each dose is administered daily between Days 1-28 of each 28 day treatment cycle. Participants will also be asked to take an oral dose of palbociclib for Days 1-21 of the same 28 day treatment cycle. If participants don't experience any severe side effects, they will continue to receive study treatment in 28 day cycles. A new group of participants will receive treatment at a higher dose if deemed appropriate following a review of safety from the first cycle of treatment in the prior group of participants. Part 2) Dose Expansion stage where the recommended dose determined from the first stage will be administered to a new group of participants. Participants in this group will also receive OP-1250 daily between Days 1-28 of each 28 day cycle, and will also take an oral dose of palbociclib for Days 1-21 of the same 28 day treatment cycle. Treatment with both OP-1250 and palbociclib will continue for up to one year (or longer if agreed by the investigator and sponsor) after the first dose is administered, unless severe side effects are experienced. Safety and tolerability will be assessed frequently in every cycle for both stages. Pharmacokinetics for OP-1250 and palbociclib will be assessed for all participants (both Part1 and Part 2) using blood samples. Participants will also be asked to complete an electrocardiogram (heart scan) every at least every second cycle for 9 months after starting in the study. It is hoped this study will determine the safest dose of OP-1250 that can be administered to patients with breast cancer, and that this research will also show that giving OP-1250 in combination with palbociclib is safe and effective against the cancer spread.

The Deadly Koolinga Chef Program (DKCP) is an invited Aboriginal community-based children and adolescent cooking and nutrition program that aims to build nutritional health literacy for improved and sustained health and well-being. The primary hypothesis is that a nutrition and cooking intervention that is developed, designed, delivered and controlled by Aboriginal community will enhance the development of food literacy, and the secondary hypothesis is that the community-controlled program will lead to improved individual and community nutritional outcomes. The primary study objectives are to (1) provide nutrition and cooking instruction for kitchen safety, meal planning and budgeting, preparing, cooking and storage of food; (2) improve awareness of the importance of nutrition and healthy eating in the prevention and management of chronic diseases; (3) determine participants’ nutritional intake and dietary changes; (4) evaluate overall social and emotional well-being. The program will cater for 6 - 12 year old children on a weekly basis through the school terms, with workshops for adolescents (13 - 18 years), pregnant women and breastfeeding mothers for a two-year period.

This study is investigating if cancer rehabilitation delivered via telehealth is effective and cost-effective as compared to usual care without rehabilitation. Who is it for? You may be eligible for this trial if you are aged 18 years or over, receiving or recently completed cancer treatment whilst living independently in the community. Study details Participants will be randomly allocated to one of two groups: 1) Telerehabilitation comprising online group exercise; or 2) usual care without rehabilitation. After completion of an 8-week exercise program, data regarding quality of life, physical capacity and health service utilisation will be collected. It is hoped this study will determine the feasibility and effectiveness of cancer rehabilitation delivered through telehealth.

This project will compare the repair of early tooth enamel decay after chewing with two sugar-free gums containing the major milk protein casein combined with calcium (called CPP-ACP). One gum will contain CPP-ACP made using an enzyme called trypsin that originates from pigs. The other gum will contain exactly the same ingredients as the first gum including the same amount of CPP-ACP but the CPP-ACP in the second gum will be made using trypsin that originates from a fungus. To test these abilities of these two gums to repair early decay, pieces of pre-sterilized human enamel with artificially-created early decay will be attached to custom-made removable denture-like appliances that will be worn by 10 human participants for 40 minutes four times a day for each of two 10-consecutive weekday treatment periods, and chew gum for the first 20 minutes the appliance is worn each time. A different gum will be chewed during each treatment period. The two treatment periods will be separated by a one-week washout period when the participants will rest from the study while new pieces of enamel are attached to their appliances before they cross-over to the other gum. The order the two gums are chewed will be random and unknown to the participants or researchers.. The hypothesis is that the abilities of the two gums to repair the early decay will be equivalent.

Gender affirming hormone therapy is used by many transgender (trans) individuals and results in considerable changes in sex hormone levels (testosterone and estrogen). These hormonal changes affect skeletal muscle mass, but the underlying effects on physiological measures, such as aerobic fitness and muscle strength, as well as molecular markers such as epigenetics are unclear. Given the use of gender affirming hormone therapy by trans individuals is rising, it is critical that we further examine the short and long-term impacts of these therapies, with potential for research in this area to improve outcomes and personalise care for trans people and promote the fair inclusion of trans communities into sports commonly separated by gender. The aim of this project is to further understand the effects of gender affirming hormone therapy on physiological and molecular measures of skeletal muscle health and function. This study will include transgender participants commencing gender affirming hormone treatment, as well as of cisgender participants not undergoing any treatment, with all participants followed up over 12 months. The study involves participants undertaking aerobic and strength fitness tests and body composition scans and providing de-identified blood and muscle samples for analyses. Multiple outcomes will be assessed over 12 months, including changes in fitness tests, body composition, and epigenetic and blood markers such as DNA methylation and blood glucose. Outcomes will be compared before and after 6 and 12 months of hormone therapy in transgender individuals, and compared to outcomes in cisgender individuals, allowing us to assess the effects of gender affirming hormone treatments in depth.

Following the closure of an enterostomy, post-operative fasting for a few days has been the norm, however, this prolonged fasting may not be necessary. Thus, we are planning a randomised control trial that compares the efficacy of early feeding with feeding after post-operative fasting in paediatric patients undertaking elective enterostomy closure. The hypothesis is that early feeding leads to shorter length of hospital stay, reduced pain, reduced rate of surgical complications and improved parent/carer satisfaction at discharge from hospital.

The aim of this study is to evaluate safety and tolerability of SVT-4A1011 as a treatment for Insomnia together with preliminary efficacy. The treatment consists of selected bacterial species that are naturally found in the digestive tract. They are a research focus for their important role in many conditions related to gut health. Bacteria play an important role in the function of the immune system, digestive health, inflammation and gut/brain axis. Several research studies have identified certain gut bacteria having direct interaction and regulation of key neurotransmitters and pathways associated with sleep including influencing the host circadian rhythm. This study will help determine how safe and effective SVT-4A1011 is as a stand-alone therapy in treating Clinically Diagnosed Insomnia. The hypothesis of this study is that, twice daily consumption of the study drug SVT-4A1011 will result in improved quality of sleep in individuals with clinically diagnosed insomnia.

The RIVASTIM trials aim to identify strategies to improve immunological responses to a 3rd booster dose of the mRNA Pfizer Comirnaty COVID-19 vaccine in a cohort of kidney transplant patients who have failed to achieve an adequate immune response to a standard two-dose COVID-19 vaccine course. Kidney transplant patients are a highly vulnerable group of immunosuppressed patients who suffer from disproportionately high COVID-19-related morbidity and mortality. The transplant medication sirolimus shows promise in enhancing immune responses to COVID-19 vaccination. In this study kidney transplant patients receiving standard of care immunosuppression with tacrolimus, mycophenolate, and steroids will be randomised to either switch from mycophenolate to sirolimus, or remain on standard of care immunosuppression. Four weeks after randomisation, participants will receive a 3rd COVID-19 vaccine dose, and immunological responses will be assessed 4-6 weeks later.

The study is evaluating the feasibility of hyper-accelerated partial breast irradiation therapy in women with breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above who has been diagnosed with invasive non-lobular breast carcinoma and have had breast conserving surgery. Trial details: All participants in this study will undergo a procedure called hyper-accelerated partial breast irradiation. This involves catheters implantation under general anaesthetic followed by three treatment doses of brachytherapy radiation. All participants will be followed up for a maximum of 10 years to assess for recurrences and quality of life, which will involve performing annual mammogram scan and completing questionnaires (6 weeks, 6 months and annually for 5 years). A peripheral blood sample and the resected tumour sample will also be assessed at the time of commencing therapy (and then 6 weeks,1 year, 5 year and 10 year) to identify potential biomarkers of local disease recurrence. It is hoped that this study may show that hyper-accelerated partial breast irradiation therapy is feasible, safe, and efficacious for the treatment of locally advanced breast cancer. It may also help to identify biomarkers to allow for accurate selection of patients who are suitable for this treatment in future.

Inflammation is a key component in the cause of ischemic stroke. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever, and acute/recurrent pericarditis. There is an increasing body of evidence in the literature supporting a beneficial role of long-term colchicine therapy in prevention of cardiovascular disease. Low-dose colchicine use has also been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this trial is to assess the effect of low-dose colchicine (0.5mg/daily) in addition to optimal medical therapy of cardiovascular outcomes in stroke patients with evidence of persistent coronary inflammation (based on hs-CRP). We hypothesise that addition of colchicine to optimal medical therapy in patients post-stroke, who have biomarker evidence of persistent inflammation will reduce recurrent cardiovascular events.