ANZCTR search results

The purpose of this study is to compare the immune responses within cancer tumours which have and have not been treated with stereotactic ablative body radiotherapy (SBRT). Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have cancer in the head or neck regions. Study details All patients undergo SBRT to tumour sites, which delivers a high dose of radiotherapy to the tumour. This will occur across 1-8 treatment sessions (fractions), and most likely 3-5 fractions for one tumour site, and one fraction will be given each day over 30 minutes. Depending on the tumour site, fractions can be given on consecutive weekdays or every 2nd weekday. Your treatment sessions will depend on the number of tumour sites that the doctor considers can be safely treated with SBRT. Before and after SBRT, there will be PET imaging using novel tracer 89Zr-Df-IAB22M2C to track immune cells in the tumour and in the whole body. Blood tests will also be performed before and after SBRT. It is hoped that this research will provide information on how to best deliver immunotherapy with SBRT radiotherapy, thus improving treatment of head and neck cancer.

Paltusotine is an oral somatostain receptor 2 (sst2) agonist being developed for the treatment of acromegaly. This single cohort, 2 period study will evaluate the relative bioavailability of two paltusotine tablet strengths in healthy volunteers. Participants will receive 1 dose of 2 x 30mg and 1 dose of 3 x 20mg of paltusotine, across 2 periods in a randomised format as follows: Period 1: 6 Participants to receive 1 dose of 2 x 30mg, 6 Participants to receive 1 dose of 3 x 20mg. Period 2: Participants to receive the other dose to what was received in Period 1. Participants will receive each dose with approximately 240ml of water, after a 10 hour overnight fast. Participants will then fast for further 4 hours after dosing. There will be 10 to 14 days between doses.

The aim of this cutting-edge micro-randomised trial is to evaluate the effectiveness of a new Just-In-Time Adaptive Intervention delivered via a smartphone app for people who want to gamble less. This app will provide users with in-the-moment support for gambling cravings, high-risk situations, and positive outcome expectancies to prevent gambling episodes. Participants will complete very brief real-time assessments three times per day via the app, which will be used to determine their eligibility for a real-time intervention. Participants who are eligible to receive an intervention at each assessment time point will be micro-randomised to one of two conditions: a tailored intervention condition or a no-intervention control condition. Participants who are assigned to a tailored intervention condition continue completing intervention activities in a loop until they indicate they no longer need support or close the app. Participants will also complete pre-intervention, post-intervention, and 6-month follow-up evaluations to determine change over time. In so doing, this trial will inform the optimisation of this intervention, evaluate the efficacy of the intervention, and explore when and for whom the intervention is effective.

Hormonal testing can be performed at different stages during ovarian stimulation, either alone or combined with ultrasound (Kwan et al., 2014). Currently, hormonal testing is mostly performed via serum-based hormonal assay in clinical practice. Levels of Estradiol (E2), Luteinizing Hormone (LH) and Progesterone (P4) can provide information on ovarian response to stimulation, risk of ovarian hyperstimulation syndrome (OHSS), drug regimen required (type of gonadotrophin and type of protocol), whether dose adjustment of gonadotrophins is needed during treatment and optimal time to trigger follicular maturation (Kwan et al., 2014; Meyer et al., 2015; The ESHRE Guideline Group On Ovarian Stimulation et al., 2020). Kinder is a non-invasive in vitro diagnostic device for measuring urinary fertility hormones (FSH, LH, Estrone-3-glucuronide (E1-3G) and Pregnanediol-3-glucuronide (PdG)). The assay test system is for use by both health care professionals in a clinical setting and non-professionals in a home care setting under the guidance of a health care professional. Results will be sent, as de-identified data, to be interpreted by a health care professional as an aid to clinical decisions (Planet Innovation Regulatory Strategy Plan version 3.0). Correlation of serum concentration of fertility hormones and their urinary metabolites represents one of the critical data gaps in incorporating the use of Kinder device into the daily practice of ART treatment. This study will provide pilot data on such correlation.

Recent studies on melanoma have shown that survival and response to treatment can related to gut microbiome diversity and richness. All bacteria produce molecules, known as metabolites, that can alter immune cell function. This study aims to assess whether people with melanoma who are being treated with a checkpoint inhibitor (immunotherapy) have any key differences in their bacterial metabolites (metabolome) that may determine whether they are likely to respond to their immunotherapy treatment. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with resected and unresectable melanoma and you are undergoing checkpoint inhibitor therapy. Study details All participants who choose to enrol in this study will be asked to provide a blood sample and a faecal (stool) sample for testing. This will occur during a clinic appointment lasting no more than 20 minutes. Participants will be asked to provide these samples at the time of enrolment, at 6 weeks and then either (i) at the 6 month mark, or (ii) earlier if the immunotherapy treatment stops working. It is hoped this research will determine if there are any key metabolite differences between melanoma patients who do respond to immune checkpoint inhibitor therapy, and those do not respond to this treatment. We hope to use our research findings to investigate more effective cancer treatments for patients in the future.

The primary hypothesis of the study is to automatically classify a sample of call recordings obtained from our telehealth partners according to risk of suicide. Risk of suicide is defined as low (levels 1 and 2 on the Columbia Suicide Severity Rating scale, CSSR-S) and High (levels 5 and 6 on the CSSR-R). Call recordings will be sourced from two industry partners including On The Line who administer the Suicide Call Back service and the Australian Federal Police who administer 000 emergency services in the Canberra, Australia region.

This study aims to assess the impact of a personalised support-based intervention on the distress levels in children whose mother has been diagnosed with and is undergoing treatment for breast cancer. Who is it for? You may be eligible for this study if you are the child(ren) of a mother who is undergoing treatment for breast cancer at the Perth Breast Cancer Institute (the clinical arm of Breast Cancer Research Centre – WA). Offspring participants aged between 14-24 and their mother may be eligible to enrol in this study, please refer to the 'inclusion criteria' section for additional information. Study details All participants who choose to enrol in this study will undergo a 30-60 minute consultation with a clinical psychologist to determine their mental status and level of distress. For participants aged 14-17 years, an appointment for the consultation will be arranged with a parent / caregiver in attendance. Participants aged 18 or older will be contacted by phone or email to obtain consent once the parent has discussed the study with them. After consultation with the clinical psychologist, participants will be allocated to one of four cohorts: 1. nil further action needed 2. provision of written and verbal information 3. referral to external agencies for additional support (e.g. Relationships Australia, Canteen, a private psychologist or a Community Mental Health Service) 4. up to 6 in-house counselling sessions with one of the trained clinical psychologists at Breast Cancer Research Centre – WA All participants will then be asked to complete up to 3 questionnaires 3-4 months after they enrolled in the study. It is hoped this research will provide preliminary results on the efficacy of these treatment strategies, and that personalised referral to treatment services may lead to a reduction in the distress of children whose parents have breast cancer.

Antimicrobial resistance- AMR (in particular antibiotic resistance) has been identified as one of the biggest threats to global health by the World Health Organization. If no sustained action is taken now, >10 million people could die each year by 2050 directly due to antimicrobial resistance (O'Neil, 2016). Nutritional interventions have been identified through literature review to have potential to combat against AMR. The most promising strategy is the popular use of probiotics (“live microorganisms which when administered in adequate amounts confer a health benefit on the host”) to restore and boost the beneficial microbes in our bodies. Another nutritional strategy for modulating the microbiota is consumption of dietary fibre and prebiotics that can be metabolized by microbes in the gastrointestinal tract. The functional food group of fermented foods, defined as foods or beverages produced through controlled microbial growth, and the conversion of food components through enzymatic action is another potential candidate nutrition strategy for combating AMR. Another food group that shows promise includes the polyphenol-rich food, polyphenols are a group of plant metabolites with potent antioxidant properties, which protect against various chronic diseases induced by oxidative stress. Lastly, interest in the use of trace metals as antimicrobial agents such as zinc, selenium, copper, iron, manganese, and other trace metals are increasing. Trace metals are naturally occurring essential microelements recommended for daily intake. These minerals are present in a wide range of foods in addition to their presence in nutritional supplements. The aim of the proposed project is to conduct a small pilot proof-of-concept human study to investigate the use of combination nutritional interventions to reduce AMR. In this pilot study, we will assess whether the natural nutritional interventions enhance gut microbial diversity and profiles, reducing resistant bacteria in the gut as well as enhancing immune functions in humans. The results of this study will provide proof-of-concept evidence to support the potential role of these nutritional interventions in combatting against AMR, and therefore whether it could be implemented as an adjunct nutritional therapy for AMR.

The aim of this study is to collect information treatment and patient choice in early-stage breast cancer patients. Who is it for? You may be eligible to join this study if you are male or female, aged older than 18 years, and have early-stage breast cancer. Study details At the start of the study, all participants will be asked a series of questionnaires on demographics, perceptions about cancer treatment, and beliefs about medicine; this will be conducted by phone, online, or face-to- face. Afterwards, patient records will be reviewed for breast cancer events, and all participants will be followed up with a brief survey on treatment compliance every 3 months for the first 2 years, then every 6 months up to 5 years. It is hoped that this study will reveal how patient beliefs influence their choice of treatment, and hence allow better psychosocial understanding of breast cancer patients.

The aim of this feasibility study is to compare the effects of dance therapy in addition to usual care with conventional group-based physiotherapy in addition to usual care, on physical function in recently hospitalised adults with acquired brain injuries. Specifically the researchers of this study will examine the effect of dance compared with conventional physiotherapy therapy on physical function, mobility, self-efficacy, quality of life and satisfaction; understand patients’ preferences for dance therapy; and assess the acceptability, adherence and adverse events associated with a dance therapy program. A steering committee of consumers, dancers and the health service will co-design the dance therapy program and will meet bimonthly either face to face or online platform (given general health recommendations during the global pandemic) to discuss about the program. Adding dance to rehabilitation may have the potential to reduce hospital lengths of stay and return people to their homes earlier by enhancing motivation, providing additional opportunities for movement.