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Anxiety is common in adults with advanced life-limiting disease, adversely affecting quality of life, social relationships and daily functioning at a critical time. This current study will assess the feasibility of a larger multi-centre, randomised, double-blind, placebo-controlled Phase III trial of oral lorazepam for symptoms of anxiety in participants with advanced life-limiting disease. Who is it for? You may be eligible to join this study if you are aged 18 and above with advanced life-limiting disease receiving specialist palliative care input and experiencing symptoms of anxiety and meet all the inclusion and none of the exclusion criteria. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Arm 1 will be lorazepam and Arm 2 will be placebo. The study treatment will be commenced at a dose of 0.5mg (1 capsule) at night. If this is tolerated at Day 3, the dose will be increased to 0.5mg twice daily. A dose titration schedule with up to weekly dose review will then be followed. Each week the total daily dose may be increased by 0.5mg based on clinical assessment, adverse events assessment and HADS-A score, up to a maximum dose of 2mg twice daily (4 capsules twice daily). The study treatment will be continued for 12 weeks, unless criteria for discontinuation of treatment are met prior to this.

This is a placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of 3 doses of Nintedanib Solution for Inhalation (AP02) (0.25 mg/mL) administered using the eFlow nebulizer in normal healthy volunteers, patients with idiopathic pulmonary fibrosis and patients with progressive, fibrosing interstitial lung disease. Eligible subjects in the normal healthy volunteer (NHV) cohorts (1 - 3) will be assigned to one of three cohorts, where they will receive a single dose of AP02 (or matching placebo) via inhalation for up to approximately 20 minutes. Cohort 4 (NHV) will receive AP02 at the maximum tolerated dose (MTD) established in the first 3 cohorts and Cohort 5 (NHV) will receive oral nintedanib at 150 mg. Cohort 6 will enroll patients with IPF/PFILD and will receive AP02 at the MTD established in the first 3 cohorts. The primary objective of this study is to evaluate the safety and tolerability of AP02, with this to be evaluated in each cohort by the Safety Review Committee and through review of the adverse events, physical examination, vital signs, laboratory, oximetry and spirometry values prior to and after dosing. The secondary objectives are to determine the maximum tolerated dose (MTD) of AP02, and the nintedanib plasma and bronchoalveolar lavage (BAL) pharmacokinetics (PK) following delivery of a single dose of AP02. Sentinel dosing will be employed in the first three cohorts for this single site study with a total of approximately 24 volunteers (NHV) to be enrolled - up to 8 in each cohort with 2 sentinel subjects dose 24 hours before the remaining 6 subjects. Cohorts 4 – 6 may be run simultaneously and will enroll a total of 8 volunteers (NHV) and 6 IPF/PFILD patients.

Vitamin D deficiency remains a global public health issue, with clinical rates growing. Vitamin D deficiency is well known to be linked to musculoskeletal conditions, however there is also strong epidemiological evidence linking deficiency with diabetes, cardiovascular disease, osteoporosis, osteoarthritis and some cancers. The condition has a significant financial impact on not only individuals, but also the economy, therefore is of public health importance. As majority of vitamin D is synthesised through cutaneous exposure to the sun, it is unlikely that vitamin D deficiency is perceived to be an issue for much of the Australian population. However, vitamin D deficiency is prevalent in Australia, due to the many individual and environmental factors that impact on vitamin D status, such as skin colour, dressing habits, latitude and season. The Australian Health Survey 2011-12 identified that 23% of the population were vitamin D deficient (defined as <50nmol/L), which equivalates to approximately 4 million people (ABS 2014). Our study will look at the vitamin D status of women living in Australia in winter 2020/2021. This study will take place in Wollongong, on the South East Coast of Australia, Latitude 34.42° S, 150.89° E. We will determine which factors such as dietary intake, sun exposure and muscular strength contribute to vitamin D status. The findings of this study will not only fill this gap in the knowledge, but may also contribute to the literature which informs public health policy on vitamin D.

The purpose of this trial is to investigate the dose-related effects of intraduodenal administration of the bitter tastant, quinine, which contains no calories, on gastric emptying, gut and gluco-regulatory hormones, postprandial blood glucose and gastrointestinal symptoms in healthy female participants. We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked improvements in postprandial blood glucose. Some bitter substances also have these effects. Moreover, it has been reported that the response to bitter substances may be more pronounced in women than in men. Therefore, this study will investigate the dose-related responses to quinine in female Volunteers.

The aim of this project is to pilot a randomized controlled trial of an 8-week group self-compassion training program (Making Friends with Yourself; MFY) delivered via videoconference, for young people (14-17 years) with Type 1 diabetes. We will assess whether the program is acceptable and determine whether it is feasible to do a larger study of the program. We will do this by asking participants what they think about the program and also looking at how long it takes us to recruit participants, how many people complete the intervention, and how many of the participants are satisfied with the program. We will also collect data on self-compassion, mental health, diabetes management, quality of life, and metabolic control. This data will be collected before the program commences, after the program is complete, and again at 4 weeks after program completion. This data will help us to design future studies to test the whether the program is effective for improving mental and physical health outcomes in young people with Type 1 diabetes.

To our knowledge, there has never been published a controlled trial on exercise for PD in a tropical climate, despite regional areas such as Townsville having a high incidence of PD. This phase I trial will add new data on that topic. Our previous clinical trials (Morris et al 2009;2015) showed that hospital-based and outpatient clinic-based physiotherapy were effective for improving mobility and reducing falls in people living with Parkinson’s disease. These trials were conducted in a temperate climate (Melbourne). There is a need understand responses of PD patients in tropical climates (such as Townsville) to structured exercises programs and to determine whether outpatient physiotherapy that comprises general fitness aerobic exercises plus balance training (45 minutes) and falls education (15 minutes) twice a week for 3 months in a gymnasium setting is more effective than home-based exercises coupled with falls education. It is possible that the exercise classes could reduce disability and improve mobility in Parkinsonism.

Men in Australia and many other countries account for three-quarters of deaths from suicide (Australian Bureau of Statistics, 2019; WHO, 2014). The higher rate for suicide among men has been attributed to several factors including lethality of means, externalising of depression, substance use, and reduced social connectedness and help-seeking (Granato, Smith, & Selwyn, 2014; Mergl et al., 2015; Moller-Leimkuehler, 2002; Player et al., 2015). These factors are influenced by masculine norms. Whilst some masculine norms can have positive impacts on wellbeing, conformity to masculine norms such as stoicism and self-reliance is linked to increased suicidal ideation and behaviour (Coleman & Feigelman, 2020; Wong, Ringo Ho, Wang, & Keino Miller, 2017). Given the gendered nature of suicide and the role of masculine norms, a gendered focus, that attends to the social context of suicide by men has long been recommended for suicide prevention interventions (Canetto & Sakinofsky, 1998; Oliffe, Ogrodniczuk, Bottorff, Johnson, & Hoyak, 2012). School based programs to support young men's wellbeing became increasingly common in recent years. However, the evidence base for the effectiveness of gendered school-based programs to bring about positive impacts for young men is lacking (Gwyther, Swann, Casey, Purcell, & Rice, 2019) (Calear et al., 2016). This trial seeks to address this lack of knowledge by determining the impact of an Australian school-based program, ‘Breaking the Man Code’ workshops delivered by Tomorrow Man, that aims to challenge and transform harmful masculinities with young men with a view to ultimately reducing their suicide risk. Our cluster randomised control trial will compare participants who receive the ‘Breaking the Man Code’ workshop within their school with those who wait to receive the workshop and receive only their usual school curriculum. The primary purpose of the trial is to determine whether the workshops have positive impacts on factors that are known to contribute to men’s suicidality, including young men's intentions to seek help and recommend help to others, their perceptions of masculinity, depression risk, social support and wellbeing. The findings of the research will be used to inform the development of the workshops and other interventions for boys. The primary research hypothesis is that adolescent boys in year 10, 11 or 12 who receive the ‘Breaking the Man Code’ workshop at school will demonstrate an increase in their intentions to seek help for personal or emotional problems.

The purpose of this study is to examine several treatments for poor sleep and fatigue during chemotherapy for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older with diagnosis of breast cancer and will be receiving chemotherapy treatment for at least 6 weeks at the start of the study. Study details Participants in this study are randomly allocated (by chance) to one of four groups for 6 weeks of: 1. Cognitive behavioural therapy. Cognitive behavioural therapy is a short-term therapy technique that focuses on changing ways of thinking and behavioural patterns to improve sleep; or 2. Light therapy. Light therapy manages someone’s exposure to light, particularly in the morning and evening, to help support energy levels during the day and improve sleep overnight; or 3. Combination of treatments 1 & 2; or 4. Sleep hygiene and education therapy. Sleep hygiene and education therapy refers to a set of strategies about your behaviours and your sleep environment that support healthy sleep. Participants will be expected to complete some assessments. Assessments will include structured interviews in person or over the telephone (~ 1 hour) to assess eligibility and identify whether you have any current sleep disorders, wearing a wrist-watch like device to track your activity and sleep for the first and last two weeks of the intervention, and questionnaires you complete online or with us over the phone. If effective, results from this study will identify which treatments most improve sleep and fatigue during chemotherapy and may be used to guide routine treatments offered to women undergoing chemotherapy for breast cancer in the future.

Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment is common in clinical trials, and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure?; ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by the consent process; and iii) Exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved? Participants will include patients consented for shoulder impingement surgery with one of the orthopaedic surgeons from St Vincent’s Public Hospital Melbourne (SVHM). It is expected that a total of number of 80 participants will be recruited to this study. The primary outcome will be the proportion of people willing to opt in to the proposed hypothetical placebo surgery trial of arthroscopic subacromial decompression (ASD) post each consent scenario. The focus of this feasibility study is how to optimise patient recruitment to a future trial comparing ASD of the shoulder joint to anaesthetic and skin incision only. Outcomes from this study will inform a future placebo-controlled surgical trial for ASD.

Methadone is an opioid medication used as a pain reliever medication and as a way of reducing withdrawal symptoms for those patients addicted to opioids. It is in the same class of drugs as codeine, oxycodone, morphine and fentanyl. These drugs are commonly employed to manage acute pain, such as that inflicted by surgery. Due to opioids having significant side effects alongside addictive properties, reducing the dose of such potent drugs is important, especially to avoid patients becoming dependent on them. Such adverse effects range from nausea, constipation and sedation to respiratory suppression, overdose and death. Laparoscopic surgery is a minimally invasive, moderately painful procedure commonly employed in general and gynaecological cases. Such procedures, especially gynaecological surgeries can be notoriously difficult to manage post-operative pain where no ideal analgesic regimen has been established. Conventionally, potent opioids like fentanyl and morphine are employed during surgery with patients frequently requiring opioids in both the PACU, and after discharge. This carries substantial risks and adverse effects. Methadone may offer an appealing alternative to current strategies. If the amount of post-operative opioid required can be reduced, not only will patients benefit in terms of greater comfort and fewer dose-related opioid adverse effects, but recent concerns about overprescribing of discharge opioids may be alleviated Hypothesis This study hypothesises that intraoperative methadone use will reduce PACU opioid consumption. As a result, we also predict that we will be able to reduce opioid dose (in morphine equivalents) consumed after discharge, at one week.