ANZCTR search results

The purpose of this study is to assess the use of a 3D-printed scaffold, which is designed and tailored for each person, for the purpose of re-growing jaw bone. This may allow a more appropriate bone height for placement of dental implants, and could assist in making the future plate/denture fit better and be easier to clean. Who is it for? You may be eligible to join this study if you are aged between 18 years and 60 years old; have had head/neck ablation and reconstruction surgery within the previous 6-24 months; have a discrepancy between the old and new jaw bone; and have NOT undergone any radiation treatment previously. Study details Participating in this study involves having an operation to place the 3D printed scaffold under a general anaesthetic, which is likely a 2-3 hour procedure. The reconstruction plate used to heal your mandible after your initial tumour removal surgery will be removed at the same time. A small amount (2-3mls) of bone will be taken from your hip, and cells from your blood will be taken and placed in the scaffold to encourage bone formation. This operation will need an overnight stay to make sure you are healing well before going home. Once the scaffold is in place, a repeat CT scan will be performed 9 months after scaffold insertion to measure the amount of extra bone formation. Another 1-2 hour operation will then be performed to place dental implants, which is the next key step in getting teeth after your tumour surgery. This procedure is a day surgery procedure, so you will be going home on the same day. You will be asked to fill out surveys at various stages of the treatment to help us determine the best way to provide this care for future patients. It is hoped that this study will show that using this tailored, 3D-printed scaffold can help regenerate bone in the jaw; and thus improve dental rehabilitation outcomes for patients who have had ablation and reconstruction surgery.

Lung cancer is the largest cause of cancer related death in the world. Low dose computed tomography (LDCT) is a scan that reduces deaths from lung cancer by detecting early disease, which is currently being investigated as a screening program for current or former smokers as part of the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital. Physical activity is a potentially modifiable risk factor for the development of lung cancer. Therefore, the purpose of this study is to see if it is feasible to implement an exercise program as part of lung cancer screening to modify an individual’s risk profile. Who is it for? You may be eligible for this study if you are aged 55 to 80 years, are already enrolled in the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital (NCT02871856), and are a current or former smoker estimated to be at a high risk of lung cancer. Study details Participants will be randomised (i.e. allocated by chance) to either the intervention group, which will receive a home-based exercise program, or to a control group that will not receive the exercise program. The home-based exercise program will involve an 8 week unsupervised program consisting of education, aerobic exercise, and resistance training, with weekly progress reviews and goal setting. Weekly progress reviews and goal settings involves a telehealth or telephone consultation of up to 30 minutes per week. Targets for aerobic exercise over the week will range up to 300 minutes per week divided over multiple sessions. Resistance training will be up to two 30 minute sessions per week. Participants allocated to the exercise program will also receive written materials describing Australia’s physical activity and sedentary behaviour guidelines, and will continue to receive usual care, defined as their current medical, nursing and allied health support. Participants in the control group will receive usual care and access to the written materials only. 9 weeks after commencing the intervention or control treatments, all participants will be assessed for feasibility of the intervention by adherence to exercise sessions, as well as for safety of the intervention by number of adverse events occurring during or within 60 minutes following the intervention. Participants will also be assessed for any changes in known contributors to lung cancer risk, including physical activity levels, exercise capacity, muscle strength, body composition, and overall health and wellbeing at 9 weeks and 6 months after commencing the intervention or control treatments. It is hoped that this study may show that the addition of a home-based exercise program to lung cancer screening is feasible, safe, and is able to improve the lung cancer risk profile of current or former smokers.

Closed Loop Medical has developed a neuromodulation and recording system capable of recording the electrophysiological response to each stimulus pulse. Closed Loop Medical have adapted a commercially available Spinal Cord Stimulation system approved for treatment of chronic intractable pain of the trunk and/or limbs to provide a fully implantable SNS system akin to those commercially available but, which can also use the recorded electrophysiological response from the sacral nerves to drive a feedback-controlled closed-loop therapy and aid in nerve targeting. This study is designed to assess the feasibility and safety of the Closed Loop Medical SNS System in the treatment of symptoms of OAB.

Anxiety and depressive disorders, which frequently co-occur, are the most common mental disorders in older adults (Beekman et al., 2000; Sunderland et al., 2015). The co-occurrence of anxiety and depression in older adults is associated with worse outcomes than either disorder alone, including increased risk of cognitive decline and dementia (de Beurs et al., 2009; Paterniti et al., 2002; Wetherell et al., 2004). Anxiety and depression can be successfully treated in community-dwelling older adults using psychological interventions, with the strongest evidence for cognitive behavioural therapy (CBT) (Wuthrich et al., 2021). When symptoms cannot be managed in the community or when individuals are at risk of self- harm, older adults are managed in inpatient wards. With the population rate of overnight mental health-related hospital stays for older Australians increased by a striking 82.4%, from 2006–07 to 2018–19 (Australian Institute of Health and Welfare, 2020), more needs to be done to assist older adults in inpatient wards. However, there are no evidence-based psychological interventions in inpatient settings that target anxiety and depression in older adults. Instead, psychotropics are used, including benzodiazepines which increases risk of falls and cognitive decline. Therefore, interventions developed using evidence- based practice that are feasible in this challenging setting are needed. Challenges to psychological management include disorientation of patients in these settings, variable attendance, and admission durations. Therefore, this project brings together experts in older adult mental health across multiple disciplines (clinical psychology, biostatistics, primary care) with clinical practitioners in inpatient services to co-design a group therapy intervention and evaluation procedure.

Tranexamic acid is an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, which has also been shown to affect immune function and inflammation. There is a strong biological rationale suggesting that tranexamic acid may reduce micrometastases at the time of surgery and so reduce the risk of longer term cancer-recurrence. Therefore, the aim of this nested study is to assess the cancer-free survival of a subpopulation of participants involved in the TRIGS trial (NCT04192435) undergoing surgery for gastrointestinal cancer, who are planned to receive either tranexamic acid or placebo. Who is it for? You may be eligible for this study if you are aged 18 years or over, are enrolled in the TRIGS trial, and are scheduled for elective or semi-elective (inpatient) open or laparoscopic-assisted (i.e. keyhole) gastrointestinal cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal). Study details All participants will be assessed for cancer-free survival at 5 years after gastrointestinal surgery using state cancer registries to determine the incidence of all-cause mortality and overall survival at 5 years post-surgery. It is hoped that this study may show tranexamic acid improves cancer-free survival, improves overall survival, and reduces all-cause mortality when administered at the time of gastrointestinal cancer surgery, which may help to guide the treatment of gastrointestinal cancer patients in future.

RES@T-A is a program for teenagers who play video games at problematic levels – that is, their gaming interferes with at least one important area of their life such as schoolwork, relationships, mental health or physical health. The program was initially developed by German Psychiatrist Dr Kerstin Paschke and her team at the German Center for Addiction Research in Childhood and Adolescence at the Hamburg University Medical Centre. Over the past two years the program has been through multiple revisions involving both the German team and an Australian team led by Ass. Prof. Wayne Warburton at Macquarie University in Australia. The RES@T-A program being currently offered is the Australian version of what we believe will be close to the final version of the program. The German equivalent has already been successfully trialled at Hamburg, and the results there suggest the program can be very helpful for teenagers with problematic gaming, and for their families. The current study aims to evaluate the effectiveness of the program in terms of a range of outcomes, including levels of problematic gaming and screen use, mental health, physical health, sleep, cognitive function and socioemotional development. There are few good quality trials of programs for screen disorders, and very few well conducted studies looking at cognitive function in teens with problematic screen use compared to those without problems. The current study aims to address this gap with a thorough evaluation of the RES@T program and by collecting high quality data on cognitive function in program participants with problematic video game use and comparing to normal teenagers with no such problems..

AXA-042 functions through a multi-cellular mechanism to re-engage the innate immune response. This first-in-human study is planned to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics (PD) of AXA-042 as monotherapy in subjects with advanced solid tumors. Who is it for? You may be eligible for this study if you are aged 18 years or over, have a diagnosis of a locally advanced or metastatic solid tumor, and are refractory or intolerant to standard of care therapies. Study details All participants will receive AXA-042 as an intravenous infusion over 30 minutes on day 1 of each 21-day treatment cycle. This will continue until disease progression, withdrawal of consent, discontinuation from the study, or toxicity that in the opinion of the Investigator or Sponsor requires study treatment discontinuation, or up to study completion, whichever occurs first. Participants will be enrolled in one of the estimated 4-5 cohorts with starting dose at 0.0001 mg/kg of AXA-042 for the duration of their treatment. The dose will be increased by up to 3-fold in each subsequent cohort, after review of safety data, to determine the maximum tolerated dose. 3 participants will be enrolled in each cohort. Participants will be monitored for adverse events throughout their treatment until at least 30 days after their last dose of study drug. Participants will also have blood samples taken throughout day 1 (and in subsequent cycles on certain days) of treatment after receiving AXA-042 to assess drug absorption, distribution, metabolism, and excretion. Preliminary efficacy and pharmacodynamics will be determined through objective response rate, progression-free survival, time to response and overall survival and pharmacodynamics data on cytokines and other immune response biomarkers in response to AXA-042 treatment. It is hoped that this study may show that AXA-042 is safe and effective for the treatment of advanced solid tumors, which may lead the way for larger efficacy trials in future.

This research project is being undertaken to investigate and bring more clarity to the highly contentious management technique of sucrose ingestion prior to exercise in individuals with McArdle disease. While the technique has theoretical and physiological merit, the current guidelines regarding conditions under which the technique should be deployed are severely inadequate. The research aims to more clearly define exercise and activities of daily living in which the prior ingestion of sucrose would be of benefit. The project involves participants completing a series of clinical exercise trials with and without the prior ingestion of sucrose under the guidance and supervisor of highly qualified and highly experienced Exercise Scientists and Exercise Physiologists.

Women with a germline BRCA1 or BRCA2 mutation have markedly increased risks of early-onset breast cancer. The purpose of this study is to assess the association between hormonal contraceptives and breast cancer risk for BRCA1 and BRCA2 mutation carriers, using individual participant data from several cohort studies that have collected prospective data. Who is it for? This study will assess data on females who are aged 18 years or older (who were born after 1920), have a pathogenic (class 4 or 5) BRCA1 or BRCA2 germline mutation, do not have a personal history of cancer (except non-melanoma skin or CIN cervix) or history of bilateral mastectomy at cohort entry and have follow-up information available. Study details It is hypothesised that: 1) Current hormonal contraception is associated with an increased risk of breast cancer for BRCA1 and BRCA2 mutation carriers that decreases with time since last use 2) The association between current hormonal contraceptive use and breast cancer risk for BRCA1 and BRCA2 mutation carriers does not differ from that for the general population 3) Duration of use, age at first use, and use before first birth are not associated with breast cancer risk independently of current use and recency of use. Studies of the association between oral contraceptive pill use and breast cancer risk for BRCA1 and BRCA2 mutation carriers have had conflicting results and there are no data are available regarding the risk of breast cancer associated with the use of other types of hormonal contraception, such as hormonal implants and hormonal intrauterine devices in BRCA1 and BRCA2 mutation carriers. Quantifying any association between use of hormonal contraceptives and breast cancer risk is very important for these women, because it will help optimise their personal breast cancer risk management plan.

The goal of this study is to undertake rigorous scientific evaluation of the most popular Australian high-quality smoking cessation app. Screen2Quit (formally known as My QuitBuddy) in current smokers scheduled to undergo lung cancer screening. Who is it for? You may be eligible for this study if you are aged 55 years and over, you currently smoke, and you are eligible for lung cancer screening. Study details Participants will be randomised (i.e. allocated by chance) to either receive access to the Screen2Quit app, or will be directed to a tailored smoking cessation resources webpage. Participants in the Screen2Quit group will be sent a link to download the app to their phone, through which users may enter their planned quit date, smoking history, and set goals for quitting smoking. The app sends daily reminders and provides daily updates on health benefits of quitting, money saved, can be tailored to interact with the participant at self-identified "danger times" for smoking. Each participant’s use of the app will be determined through questionnaires and by accessing app analytics. Participants who do not receive access to the app will be directed to an online resource according to their jurisdiction (e.g. Queensland participants will be directed to the Qld government smoking cessation website QuitHQ). Participants will be instructed to use the app/web page resources ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating health team (e.g. Quitline counselling, pharmacotherapy). All participants will be followed-up for 12 months post-enrolment to assess their self-reported quit rate, biochemically verified abstinence from smoking using a urine test, quit attempts, motivation, and use of counselling/pharmacotherapy. It is hoped that this study may show that the Screen2Quit app, when used with usual care, increases quit rates compared to usual care alone in smokers undergoing lung cancer screening.