ANZCTR search results

This study aims to examine the impact of hypofractionated radiotherapy (HF-RT), which involves delivering radiotherapy over a more intensive schedule, in patients with newly diagnosed Grade 4 glioblastoma. Who is it for? You may be eligible for this study if you are aged 18 to 70 years and have a newly diagnosed, histologically confirmed WHO (5th edition, 2021) Grade 4 GBM, IDH-wildtype, and have been placed on Stupp protocol for treatment. Study details Participants will be randomly allocated to either receive 4 weeks of hypofractionated radiotherapy (55 Gy in 20 daily fractions, 5 days per week), or 6 weeks of conventionally fractionated radiotherapy (60 Gy in 30 daily fractions, 5 days per week). Both arms will also receive concurrent and adjuvant temozolomide chemotherapy. Data on survival, health-related quality of life and healthcare resourcing will be collected from all patients. It is hoped that findings from this study will help provide valuable data to researchers on the utility of HF-RT in glioblastoma patients.

Menstrual pain (dysmenorrhoea) affects approximately 70-80% of physically active females and has been associated with reduced exercise performance, exercise participation and quality of life. Common treatments like painkillers (e.g., Panadol, Nurofen) and hormonal contraceptives, are often accompanied with side-effects and are not appropriate for all females. Emerging evidence suggests Omega-3, known for its heart and anti-inflammatory benefits, may also reduce menstrual pain, improve mood, support muscle recovery and improve endurance performance. However, research has yet to test Omega-3 in physically active females and whether the reduction in menstrual cycle symptoms can result in improved endurance performance. This study aims to test whether Omega-3 supplementation can reduce menstrual pain and improve 5km running performance. The study will also investigate the underlying mechanisms (such as changes in menstrual blood biomarkers) and other performance measures like heart rate recovery, running economy, and fuel use during exercise.

The purpose of this study is to assess if adding Lutetium-177 PSMA-597 radionuclide therapy (177Lu-PSMA) to Androgen Deprivation Therapy (ADT) and an Androgen Receptor Pathway Inhibitor (ARPI) will be more effective for treating men with prostate cancer that has spread and can be treated with hormone therapy. Who is it for? You may be eligible for this study if you are a male aged 18 or over who has prostate cancer that has spread to other parts of the body but it can be treated with hormone therapy. This means that male sex hormones, including androgens like testosterone, can be blocked or stopped to slow cancer growth. You must have evidence of metastatic disease on imaging, a reasonable general health status (ECOG 0-2), a life expectancy of at least 12 weeks, and adequate blood and organ function. Study details All participants will be receive ADT and an ARPI as you would normally get for treatment for this type of cancer, as well as an adaptive dosing of 177-Lu-PSMA. You will have PSMA PET/CT scans, blood tests, and other routine health checks to monitor your response and side effects. It is hoped that this study will help provide important information on whether adding adaptive dosing of 177Lu-PSMA to ADT and ARPI treatment will lead to better treatment responses.

Preventive care is a critical part of the Australian and NSW health system. A key component of preventive care is addressing modifiable risks such as smoking/vaping, poor nutrition, alcohol misuse, physical inactivity, and weight (SNAP-W). We will test if a digital tool (+ usual care) is a more effective way than usual care alone for people on a orthopaedic outpatient waiting list to receive preventive care over a 12 week period. We will use three primary outcomes: i) receipt of assessment for SNAP-W risks, ii) receipt of advice for relevant SNAP-W risks, and iii) receipt of a referral for at least one support service for relevant SNAP-W risks.

In this randomised, double-blind, placebo-controlled study, 150 non-anaemic women aged 18 to 50 years with blood ferritin levels below 30 µg/L and self-reported fatigue will be randomly assigned to receive 30mg of elemental iron from microencapsulated iron pyrophosphate or ferrous bisglycinate (in combination with 70mg of vitamin C), or a matching placebo for 12 weeks. Changes in self-reported fatigue, mood, brain fog, sleep quality, restless legs, and gastrointestinal symptoms will be assessed over time. Changes in cognitive performance, as assessed by computer-based tests, blood iron stores, complete blood count, heart rate variability, and body composition, will also be examined.

DCLC has been implemented overseas for a number of years with success in reducing costs without compromising patient quality. Uptake in Australia is still sporadic as traditionally patients scheduled for elective Laparoscopic Cholecystectomy (Lap Chole) at our institution and others are admitted on the same day of surgery and discharged the following day. In early 2023, Werribee Mercy Health implemented elective DCLC in attempt to increase efficiency, reduce burden on the public health system whilst not compromising on quality of patient care. A policy was designed for patient selection along with a detailed perioperative protocol. The aim of this study is to review the effectiveness DCLC at our institution in comparison with that in literature.

Retained placenta is a common complication following medical termination of pregnancy >13 weeks' or induction of labour for fetal demise, occurring in 19% of cases. The standard of care in our hospital is to administer intramuscular oxytocin 10IU with delivery of the fetus. A small randomised controlled trial compared use of intravenous carbetocin to oxytocin in this cohort and found a significant reduction in rate of placental retention, third stage blood loss and need for surgical curettage. We aim to randomise pregnant people >13 weeks' gestation who are undergoing medical termination or induction of labour for fetal demise to either intravenous carbetocin 100mcg or intramuscular oxytocin 10IU (standard of care) for third stage management. The primary outcome is reduction in incidence of placental retention. The secondary outcomes include total blood loss with delivery, duration of hospital stay, use of additional uterotonics, blood transfusion, high dependency unit admission, incidence of infection post delivery, need for further intervention for retained products of conception and cost effectiveness between the two groups.

The GAIN-Woll study aims to improve cancer care for older people by testing whether a simple geriatric assessment can better support treatment planning for patients aged 70 years and over with advanced cancer. Who is it for? You may be eligible for this study if you are aged 70 years or older, have advanced cancer where further treatment is being considered, be receiving treatment at Wollongong Hospital or the Illawarra Cancer Care Centre, and be able to communicate in English. Study details Participants who join the study will attend an appointment with a geriatrician at Wollongong Hospital within three weeks of enrolment. During this visit, they will complete a Practical Geriatric Assessment, which takes around 10 to 25 minutes and looks at areas such as physical function, nutrition, medical conditions, and daily activities. All participants in the study receive the assessment; there is no randomisation. Based on the assessment results, the geriatrician will develop a personalised management plan. This may include referrals to allied health services and discussions about future care planning. A short report summarising the assessment results is provided to the participant’s cancer doctor to help inform treatment decisions. Participants will be asked to complete the acceptability questionnaire at the end of the study, health conditions and compliance will be assessed from medical records. It is hoped that this research will show whether using this assessment improves cancer care planning and support for older adults with advanced cancer.

ProCure is a novel online paediatric oncology medicines access database, co-designed with paediatric oncologists and allied health professionals to streamline the application process for accessing targeted therapies. Accessing off-label drugs for children with cancer is often complex, and ProCure aims to address this challenge by providing a centralised, clinician-facing resource to support drug access applications recommended by the ZERO2 Molecular Tumour Board. This study builds on findings from the ALIGN study and will be conducted as a sub-study within the ZERO2 program of research. It will assess ProCure’s uptake by ZERO2 clinicians and its effectiveness in reducing clinicians’ time spent submitting applications, and evaluate whether implementation support improves the integration of ProCure in clinical practice. Who is it for? Eligibility is limited to paediatric oncology professionals (e.g., paediatric oncologists and oncology pharmacists) who are ZERO-affiliated and have had a patient enrolled in the ZERO2 study for whom access to an off-label targeted therapy may be required. Participants are actively employed as paediatric oncology professionals and therefore at least 18 years of age. No patients or carers will be recruited, as ProCure is a clinician-facing resource intended solely for paediatric oncology professionals. Study details Physical or informational materials that will be used in the intervention: All participants receive access to ProCure. ProCure contains drug profile information, examples of previous successful access, information on application and access pathways, and integrated tools that allow clinicians to contact and share access information with the Drug Access Navigator (DAN). In addition to accessing ProCure, participants in this arm receive a co-designed Implementation Support Package (ISP). The ISP was developed using findings from ProCure beta-testing and refined with input from paediatric oncology professionals to help clinicians use ProCure and integrate it into their routine clinical workflows. The ISP will be finalised during this trial. It may include components such as educational resources (tutorials, training, reminders, and support from 'super-user' groups) or other strategies to assist clinicians in using ProCure. Participants will take part in a focus group to finalise the ISP, and they will also complete surveys and interviews to provide feedback on their experiences using ProCure and the ISP. This will help us understand how well the ISP supports clinicians to use ProCure and how ProCure assists them in preparing applications for off-label medicines efficiently. It is hoped that the result from this study will improve the uptake of recommended therapies by reducing the time, complexity, and barriers involved in accessing off-label targeted therapies.

Pholcodine is an over-the-counter cough medicine that may increase the risk of severe allergic reactions to neuromuscular blocking agents (NMBAs) used during anaesthesia. In March 2023, all pholcodine-containing cough products were withdrawn from the Australian market. This study will use a prospectively approved and maintained Western Australian perioperative allergy registry to examine whether the withdrawal was followed by changes in the number of clinically investigated allergic reactions attributed to NMBAs, compared with reactions attributed to other drugs. Monthly counts of reactions from January 2016 to November 2025 will be analysed using interrupted time-series regression, focusing on level and trend changes at the time of the pholcodine withdrawal. No additional procedures, tests or changes to anaesthetic care are introduced as part of this study; it is a statistical analysis of existing clinical registry data.