ANZCTR search results

Aboriginal and Torres Strait Islander people residing in remote communities experience the highest reported rates of food insecurity in Australia. We will test an intervention to improve diet quality for women and children, by making healthy food and drinks more affordable. Price discounts on a range of healthy food and drinks will be accessible to participants via loyalty cards, with discounts being advertised in store and locations frequented by the participant group. This research will enhance our understanding of the impact of price discounts on diet quality. We hypothesise that participants in intervention vs. control communities will have a greater increase in dietary quality from baseline.

The PARAGON-II clinical trial seeks to improve outcomes for post-menopausal women with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. The study aims to investigate if the combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates, as compared to historical controls from the PARAGON trial, in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated. Who is it for? You may be eligible for this study if you are aged 18 or older, with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. Study details Participants will be allocated to one of the two treatment groups based on the PIK3CA mutation status, then followed-up to see if outcomes are improved and what side-effects occur. Clinical assessment, imaging, blood tests will be performed. CA125 tumour and Patient Reported Outcomes will be also be assessed during the study. It is hoped that combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated.

With every respiratory exacerbation of CF, approximately 25% of patients do not return to their baseline lung function. Preservation of lung function is important for extending life and for quality of life, thus there is a need to determine the most effective empirical treatments of exacerbations. Antibiotics are a cornerstone of treatment. Most antibiotic regimens are only informed by old, underpowered, or poor-quality trials. Across Australia, CF centres use a range of approaches and antibiotic regimens. No consensus exists on the treatment of pulmonary exacerbations of CF. In addition to numerous antibiotic options, there are other unanswered questions pertaining to the use of mucolytic agents, anti-inflammatory medication and chest physiotherapy, alone and in combination. The range of regimens used for treating CF exacerbations cannot be feasibly compared using conventional clinical trials (comparing one treatment at a time to another treatment or placebo) due to the large number of comparisons that are needed. The aim of BEAT CF is to optimise the management of lung exacerbations in people with CF by systematically evaluating the effectiveness of alternative treatment options, and by implementing these findings in routine care on an ongoing basis. The initial, platform phase of BEAT CF involves the platform database. The platform collects treatment and outcome data in an efficient way from the medical records of participants, for the purpose of evaluating the comparative effectiveness of alternative treatments. The BEAT CF platform is intended to support the data capture for future, nested clinical trials. Details of any future clinical trials will be available separately as and when they are written.

SARS CoV-2 (COVID-19) is highly infectious, with each case transmitting infection to between 2 to 3 other people. Approximately 15% of COVID-19 infected individuals are hospitalised and 1 in 3 require artificial ventilatory support. Up to a third have a poor prognosis with the main cause of death being overwhelming respiratory failure and/or cardiac failure and cardiac arrest associated with a cytokine storm. Approximately 30% of hospitalised individuals will ultimately require artificial ventilatory support for deteriorating respiratory status while under clinical observation. Conservatively, at least one third of intubated people will succumb to the infection with the most common causes of death being overwhelming respiratory failure associated with acute respiratory distress syndrome (ARDS) and/or cardiac failure and cardiac arrest, both associated with cytokine storm. Over 1.9 million individuals of the 46 million infected individuals globally have died from COVID-19 infection (as of January 2021), with many more deaths projected over the next 6-12 months. Fatal outcomes are thought to be driven by inflammatory responses to the virus resulting in host-mediated tissue damage to the lung, heart, and kidney and a prothrombotic milieu. Approximately 10% of patients with COVID-19 suffer from symptoms beyond 3-4 weeks, labelled as ‘long COVID-19.’ A variety of symptoms are experienced including cough, breathlessness, fever, sore throat, chest pain and cognitive deficits. Oral colchicine has demonstrated striking anti-inflammatory properties in patients with vascular disease and a “single shot” of colchicine markedly suppresses monocyte inflammasome activation, which is pivotal in the cascade leading to the cytokine storm. Troublesome side effects with colchicine appears to be rare. Thus, this treatment may reduce the serious complications associated with COVID-19 and non-COVID-19 ARDS.

Medications to treat rheumatoid arthritis and psoriatic arthritis have possible side effects. People may be unwilling to take them if they are unaware of the benefits. Educational tools using pictures may improve people’s understanding of arthritis and medications. Musculoskeletal ultrasound (US) is useful in assessment of joint inflammation and damage. It is portable, non-invasive, and allows joint structures to be seen in "real-time". It may be rapidly done by a trained user. There is strong evidence that US is of value in monitoring the severity of rheumatoid arthritis and psoriatic arthritis. Recent work by our research group has shown that patients found real-time US more useful than written leaflets or online information for understanding rheumatoid arthritis and medications used to treat it. The aim of this study is to determine if showing people with rheumatoid or psoriatic arthritis “real-time” US of their inflamed joints: i) improves their willingness to take an extra medication which turns off inflammation (Disease Modifying Anti-Rheumatic Drug, or DMARD) and ii) increases their willingness to keep taking this medication (medication adherence) This research has been initiated by the study doctor, A/Prof Peter Wong. This research has been funded by investigator-initiated grants from Pfizer. The funding bodies have no input into conduct of the research.

Takotsubo syndrome, also known as the broken heart syndrome, is an acute and commonly reversible heart dysfunction characterised by changes in the structure of the heart. The condition is frequently triggered by a sudden physical or emotionally stressful event. It has long been postulated that an excess of the “fight or flight” hormones adrenaline and noradrenaline (collectively called catecholamines) caused by substantial activation of the sympathetic nervous system in the heart might play a key role in the development of this syndrome. However, this has not yet been proven, and the exact mechanism of Takotsubo syndrome remains subject to debate. The research project aims to better understand the biological mechanisms that cause this syndrome. In this study, we will, for the first time, directly measure the amount of catecholamines released from the heart in affected patients and explore its association with impaired heart function characteristic of the condition. Understanding the relevant mechanisms will allow more tailored therapies to further improve the management and outcomes of patients suffering from broken heart syndrome.

This trial aims to determine the effect of cognitive bias modification on fear of cancer recurrence or progression in patients with breast and ovarian cancer. Who is it for? You may be eligible for this study if you are aged 18 or above, have been diagnosed with a breast or ovarian cancer (unless you are receiving palliative care), and are currently struggling with a fear of cancer recurrence or progression. Study details Participants will be randomly allocated (by chance) to receive cognitive bias modification training (CBM) or a placebo. . CBM is an intervention that is administered online and trains people not to interpret ambiguous situations in a threatening way. Participants will receive four cognitive bias modification sessions over the duration of 14 days and will be required to answer a number of questionnaires before the trial, and both 14 and 28 days after the trial has commenced. It is hoped that this study may demonstrate that cognitive bias modification is effective in reducing fear of cancer recurrence and progression in patients with breast and ovarian cancer, and may help to reduce pain, anxiety, and depression, and improve quality of life.

Prostate cancer is the most common cancer in men, and the second leading cause of cancer deaths (25%) in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. The purpose of this study is to determine whether Photodynamic Therapy (PDT) is an effective and safe treatment option for patients with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male with prostate cancer. Study details Participants in this study will receive one of two treatments, with the treatment decided by chance. The two treatments participants may receive are: 1. Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light along with 25 min light therapy using a red-light laser that is delivered through a rectal probe. 2. The Photodynamic Therapy described above plus additional whole body red-light therapy, which involves lying in a red-light-bed for 25 min 4 hours after the PDT rectal laser therapy. These treatments will be provided to participants 6 times over a 9 week period. Participants will complete an assessment at baseline and at 12 weeks where they will provide a blood and urine sample, and have their prostate measured. It is hoped that this research will help determine whether Photodynamic Therapy is an effective and safe option for the treatment of prostate cancer.

The purpose of this trial is to assess the efficacy of cannabidiol (98% CBD) for sleep disturbances in healthy adults. This study will compare the botanical CBD with a placebo and evaluate its efficacy via the PROMIS sleep disturbance instrument. The study will take place in 4 sites; Brisbane, Sydney, Lismore and Melbourne. In total, the study will successfully enrol 438 participants. Eligible participants will be between 18 to 65 years old, considered to be generally healthy and self-reports sleep difficulty and quality. The trial will be 10 weeks, with an initial two-week titration period and a phone call one month after stopping medication. The study will involve a 15mg CBD per soft gelatin capsule or placebo capsule that is similar in appearance, smell and taste. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulted into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Participants will take 1 capsule after breakfast and 1 capsule 30 minutes before bed and build up to a tolerance/ maximum dose during the titration period with the maximum morning dose being 2 capsules and the maximum night dose being 8 capsules. After the titration period, the participants will stay on their maximum dose for 8 weeks or until they withdraw from the study. In total, the study should be 10 weeks in total with a one month follow up phone call after the ceasing the medication. The expected outcome is that a botanical CBD (98%) will significantly improve people's sleep who suffer from sleep disturbance more than the placebo.

Improving perinatal bereavement care after the loss of a baby is an urgent priority in Australia, and accessible perinatal bereavement care approaches that include early psychological support are required, Internet-based programs offer one solution to address this gap, particularly for primary care settings and those parents in rural Australian communities. The primary purpose of this trial is to evaluate the acceptability and efficacy of a new internet-delivered cognitive behaviour therapy (iCBT) support program in reducing emotional distress for parents who have experienced a stillbirth or neonatal death, compared with usual care. We hypothesise that participants who complete the online program “Living with Loss” will experience greater improvements in psychological distress and psychosocial health and wellbeing outcomes (e.g. anxiety, depression, decisional regret etc) than those in the usual care control group. It is also hypothesised that the Living with Loss” will be acceptable to participants with high rates of program satisfaction reported, and will be more cost-effective in improving psychosocial health and wellbeing outcomes than usual care alone.