ANZCTR search results

The aim of this study is to evaluate a multimodal prehabilitation model of care, designed to support patients with head and neck cancer (HNC) to prepare for the physical and psychological impacts of radiotherapy (RT). Who is it for? You may be eligible for this study if you are aged 18 years or older and you are scheduled to receive radiotherapy as a treatment for your head and neck cancer. Study details All participants who choose to enrol in this study will be asked to complete a screening survey at a routine appointment with their specialist nurse consultant. This screening will involve completing a series of questionnaires. It is anticipated that this screening survey will take 5-10 minutes to complete. All participants will then receive access to the 'Preparing for Head and Neck Radiotherapy (Prep-4-RT)' self-management resources created by the Peter MacCallum Cancer Centre. Participants will be encouraged to engage with the resources at least once prior to their scheduled radiotherapy sessions. Information provided in the resources includes videos, written and pictorial information sheets and links to other relevant resources on the topics of “introducing prehabilitation”, “what is it like to go through radiotherapy?”, “preparing for radiotherapy: how do you do it?”, “guide to feeding tubes” and “guidance for carers and support people”. If during the screening process any participants are identified to be at risk of psychological distress, malnutrition, sarcopenia, eating difficulties or poor physical functioning, they will also be referred for a one-on-one appointment with a psychologist, dietitian, speech pathologist or physiotherapist for specialist prehabilitation. At least one appointment with each of the required disciplines will be scheduled prior to the participant's first radiotherapy treatment session and further appointments will be scheduled as clinically indicated. It is hoped this research will determine whether the self-managed patient resources and specialist prehabilitation sessions are acceptable to patients with head and neck cancer and the staff involved in their care. If these processes are found to be acceptable and helpful to patients and staff, a larger trial of these care pathways may be trialled in a greater number of patients.

This trial is exploring the efficacy of coating limb implants with a galvanised silver layer for the prevention of surgical site infection. Who is it for? You may be eligible for this study if you are an adult who has undergone resection of primary or secondary musculoskeletal malignancy, and require subsequent segmental bone reconstruction of the distal femur. In addition, there will be other participant groups recruited including those requiring reconstruction following trauma or implant failure. Study details Participants will be randomly allocated to receive implants with or without a galvanised silver coating. The surgery will be performed by an orthopaedic surgeon. Participants will be asked to attend follow-up appointments for up to 2 years after the surgery to establish whether any surgical site infection or other complications have occurred. It is hoped that information from this study will establish the utility of silver-coating limb salvage implants in reducing the risk of surgical site infection

Currently, the health impacts on Australian Army trainees undergoing Infantry Initial Employment Training are unknown. Subsequently, the Australian Army has little evidence to guide prevention strategies in this population. Focused research is required to investigate health outcomes during infantry training and trial interventions to mitigate preventable health problems. With this evidence, the Australian Army can inform future policy and improve practice to preserve and optimise the health of the force, such as increasing nutrition support to trainees. Proper and adequate nutrition is imperative to achieve the aim of every army; to transform civilians into fit, capable and resourceful members. A major gap in the research conducted to date is the paucity of studies that have concurrently measured dietary intakes and physical performance and health indicators to understand whether any shortfalls in dietary intakes lead to reductions in military-relevant health and performance indicators. Moreover, there is a lack of studies that have employed an intervention informed by behaviour change theory while translating eating strategies that are widely used in elite sport to army initial training with the aim of improving training outcomes (such as performance in physical fitness assessments and measures of body composition such as fat-free mass) and reducing the risk of musculoskeletal injury. Thus, the primary aims of this study are to: • Determine the effectiveness of promoting performance nutrition behaviours (intervention) to significantly improve nutrition knowledge; increase dietary energy intakes; and/or enhance macronutrient intake ratios and/or diet quality during the 16 weeks of Infantry Initial Employment Training (IET) compared to usual practice (no intervention). • Determine the effectiveness of promoting performance nutrition behaviours (intervention) to significantly enhance body composition (in particular fat-free mass), physical fitness performance, blood markers of bone metabolism and sex hormones; and/or significantly reduce symptoms of gastrointestinal distress during the 16 weeks of Infantry Initial Employment Training (IET) compared to usual practice (no intervention). • Determine if increases in total energy and/or macronutrient intakes are associated with increases in: nutrition knowledge; fat-free mass; physical fitness assessment performance, blood markers of bone metabolism and sex hormones over the 16 weeks of Infantry IET. The secondary aim of this project is: • Determine the effectiveness of promoting performance nutrition behaviours (intervention) to reduce rates of musculoskeletal injury over the 16 weeks of Infantry IET. The exploratory aim of this project is: • Collect data from various musculoskeletal injury surveillance methods and systems in the ADF and compare injury estimates across methodologies.

This study is assessing a combined physical and cognitive intervention to improve the quality of life of men affected by prostate cancer receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible for this study if you are are an adult male who has been diagnosed with prostate cancer currently receiving primary ADT for metastatic and nonmetastatic hormone-sensitive prostate cancer. Additionally, you commenced ADT at least six months prior to enrolment and are expected to receive for another 6 months. Study details Participants will be randomly allocated to one of four arms. Arm 1 will involve concurrent physical training (performed on a stationary bike) and cognitive training, Arm 2 will involve physical training only and Arm 3 will involve cognitive training only. These 3 treatment arms will be delivered as 2 x 60-minute sessions per week over 8 weeks. Arm 4 will be a waitlist control group, where participants will be able to select one of the treatment arms to participate in upon conclusion of the study period. All participants will be asked to complete questionnaires assessing their physical and cognitive performance at the start and end of the trial. It is hoped that results from this study will help develop better treatment guidelines for brain fog and fatigue for men undergoing treatment for prostate cancer.

The aim of testing this product to ensure its safety and dose before commencing a clinical trial for efficacy in participants experiencing dizziness and vertigo. The trial will enroll 20 healthy volunteers who will receive either 4 tablets a day or 4 tablets twice a day for 15 days and then have 15 days without the tablet to monitor for safety.

The past decade has seen a rapid increase in mobile smartphone ownership, particularly among adolescents. Smartphone has been associated with mental health disorders (such as anxiety and depression), cyberbullying, poor sleep habits, poor posture and neck problems, and problematic mobile phone use (smartphone addiction), together with a decrease in general wellbeing, ability to concentrate (including in school time) and lower levels of physical activity. There have been increasing concerns regarding smartphone use among adolescents and the potential impact on health and wellbeing, including some concerns on the impact of smartphone use at school on educational and health outcomes. For example, concerns have been raised regarding students’ mobile phone use during school hours (in the classroom and playground) as a significant source of disruption impacting on attention and learning. Banning or restricting access to smartphone use in schools has been recommended by Governments across the United Kingdom, France, Canada, and in some Australian states as a potentially effective strategy to improve student health, well-being, and learning. With a change of Government in NSW, the introduction of policy within Government secondary schools, to restrict access to mobile phones during school hours, has been announced to commence from Term 4, 2023 (October). However, despite the introduction of Government policy to address the concerns surrounding mobile phone use amongst adolescents, research examining the school and student level impact of such initiatives is sparse, and so the suggested benefits are largely speculative. Prior to the introduction of new policies, a unique opportunity exists to address a current international evidence gap and undertake rigorous research to quantify the school and student level impacts of smartphone restrictions in secondary schools as well as to understand key stakeholder (teachers, parents, and students) attitudes towards and barriers to the implementation of such policy. To date, no such research has been undertaken in Australia or internationally. This study aims: to evaluate the efficacy of a secondary school environmental intervention to Restrict Access to Mobile Phones (RAMP) during school hours on student wellbeing, educational and health outcomes, and to determine the acceptability, appropriateness, and feasibility of the intervention from a teacher, parent/carer, and student perspective. A parallel-group cluster randomised controlled trial (RCT) will be conducted in secondary schools located across New South Wales (NSW). Schools allocated to the intervention group will participate in an environmental intervention designed to support the implementation of a school-level policy to restrict access to mobile phones for secondary school students during school hours.

This is an exploratory observational study of biomarkers in adults undergoing therapy for hepatocellular carcinoma (HCC). Who is it for? You may be eligible for this study if you are aged 18 and above, are undergoing therapy for HCC. Study details All participants in this study will have blood samples taken during their scheduled visits with their physician. Time points for blood tests include baseline (just prior to therapy), immediately after therapy then every 3 months, for up to 2 years. An additional time point for blood sample collection will be added at approximately week 4-6 for patients who receive routine follow imaging at the time and also for patients receiving systemic therapy. In the subset of patients with HCC referred for consideration of liver transplant assessment, blood samples will be taken every three months, prior to liver transplantation. This will be performed during their routine imaging as part of standard of care. Following liver transplantation, these patients will be followed at the same timepoints as the main HCC group. The following biomarkers will be evaluated: alfa-fetoprotein (AFP), Des-gamma-carboxy prothrombin (DCP), as well as exploratory somatic mutation and methylation markers. It is hoped that this research will help identify circulating biomarkers that can predict outcome and response to therapy for HCC.

The purpose of this implementation trial is to develop and evaluate an eHealth end-of-treatment model of care called "Emerge" for paediatric patients treated for Acute Lymphoblastic Leukaemia (ALL) and their families. Who is it for? You may be eligible for this study if you are a paediatric patient aged between 2 and 18 years who has been diagnosed with ALL or Lymphoblastic Lymphoma (LLy) and you are within the final 4 months of maintenance treatment or you have completed treatment within the last 6 months at either the Royal Children’s Hospital (Melbourne) or the Monash Children’s Hospital. Parents and caregivers of paediatric patients will also be invited to participate in this study and provide feedback on the Emerge model of care. Study details All participants who choose to enrol in this study will be asked to complete a series of screening questionnaires before receiving at least 2 online telehealth consultations with a nurse and psychosocial clinician. The screening questionnaires are aimed at identifying information needs and supportive care requirements for patients and their families so that the telehealth sessions can be tailored to best meet each participants needs. Some participants may be offered more than two sessions depending upon their needs, these will be monitored throughout the study to ensure that all participants receive the best possible care. Overall participation in this study will take 12 months. Participants may also attend interviews after their telehealth sessions to outline the components that they found to be helpful or less useful. It is hoped this research will determine whether it is feasible to deliver an online, personalised model of care to paediatric patients who have been treated for Acute Lymphoblastic Leukaemia (ALL) and their families. If this study finds that the online model of care is feasible and well received by participants, a larger trial may be conducted where the model of care will be expanded to a greater number of patients.

This study aims to assess the safety, and tolerability of ELVN-001 in healthy participants following a single and multiple ascending doses of ELVN-001 or matching placebo in three parts Part A (SAD), Part B (MAD) and Part C (FE) Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that Normal healthy male and female participants with no clinically significant medical history, and no clinically significant abnormalities on physical examination at Screening will be enrolled for this study. Study details This is a Double-Blinded, Randomized, Placebo-Controlled, Single- and Multiple- Ascending Dose Study To Assess The Safety, Tolerability, and Pharmacokinetics of ELVN-001 in Normal Healthy Participants. Part A (Single Ascending Dose): Participants will be randomly assigned to receive ELVN-001 or matching placebo at a ratio of 6:2. Participants in the Part A (SAD) will receive a single dose of ELVN-001 or matching placebo on Day 1 after a minimum 10 hour fast. Participants in Part A will remain fasted for at least 4 hours after dosing. Part B (Multiple Ascending Dose): Participants will be randomly assigned to receiving ELVN-001 or matching placebo at a ratio of 6:2. Participants in the Part B (MAD) will receive a daily dose of ELVN-001 or matching placebo after a minimum 2 hour fast from Day 1 to Day 10. Participants in Part B will also remain fasted for at least 1 hour post-dose. Blood samples will be drawn from participants on every day of the study. It is hoped that this research will determine the safe maximum dose of ELVN-001 that can be trialled as a therapy for patients with chronic myeloid leukamia. Part C (Food Effect) After SAD Cohort 5(120mg), 12 Participants will be randomly assigned to sequence 1(S1) or sequence 2(S2) with a ratio of 1:1. Participants in S1 will receive a single oral dose of 120mg ELVN-001 on Day 1 in fasted conditions and Day 6 in fed conditions and in S2 will receive a single oral dose of 120mg ELVN -001 (with water 240mL) on Day 1 in fed conditions and Day 6 in fasting conditions.

The increasing prevalence of neurodevelopmental disorders is a global concern. Autism spectrum disorder (ASD) affects approximately 1/100 children worldwide. More so, sleep disorders (SD) co-occurring with autistic traits have been more frequently reported in 40-80% of children diagnosed with ASD. These symptom constellations are strongly associated with concomitant parental stress, reduced quality of life and an economic burden to family and society. Consequently, the National Sleep Foundation identifies children with ASD as one of the highest-priority populations for sleep research. Several risk factors have been identified in the aetiologies of ASD and SD. For instance, abnormal organisation and maturation of grey matter have been linked to a negative correlation to sleep architecture. Other studies indicate that an imbalance in GABAergic and glutamatergic systems disrupts neural signalling and development with corresponding presentations of ASD behaviours linked to SD. A study suggested a correlation between more severe core ASD symptoms in children and disruption in sleep architecture. Interventions that target these shared pathologies could hold clinical benefits for ASD and SD outcomes. Repetitive Transcranial magnetic stimulation (rTMS) is an intervention of interest due to its effect on abnormal brain functions implicated in ASD. rTMS is a non-pharmacological and non-invasive brain stimulation that uses the magnetic field generated from an electromagnetic coil placed on the scalp to alter neural structures and functions. Its clinical potential has been demonstrated in several neurological conditions, with FDA approval for use in depression. A recent study demonstrated rTMS to be effective and safe in children with ASD and SD. The study showed improved sleep outcomes based on the children's sleep habit questionnaire (CSHQ) following the use of the same rTMS protocol across participants. Such one-shoe-size-fits-all (standard) treatment approaches are thought to limit the optimisation of rTMS potential, especially within a heterogeneous population. The heterogeneous characteristics such as individual alpha frequency (IAF), stimulation frequency, and age are known determinants of the intervention outcome. A chart study of IAF-guided rTMS documented improvement in ASD symptoms and sleep outcomes. Consequently, there is a sparse study on the efficacy and safety of IAF-guided rTMS in children with ASD and SD. This study aims to evaluate the efficacy and safety of IAF-guided rTMS on ASD symptoms and comorbid SD and quality of life in children and their primary caregivers based on pre-post objective and subjective measures. For the primary outcome, the study hypothesis is that IAF-guided rTMS improve sleep quality and quantity and other SD parameters. The study design is a randomised, waitlist-controlled, open-label pilot trial.