ANZCTR search results

The aim of this study is to examine whether intensive telehealth dietetic counselling, education, proactive medication management of nutrition impact symptoms, oral nutrition support +/- supplemental ('top-up') tube feeding into the small bowel will enhance quality of life for people with borderline resectable and inoperable pancreatic cancer having palliative chemotherapy, compared with usual care. Who is it for? Participants may be eligible to join this study if they are aged 18 years or above and have a new primary diagnosis of borderline resectable or inoperable pancreatic cancer. Participants will be randomised (allocated by chance) to one of two groups: usual care or intensive dietetics intervention (counselling, education, symptom management, oral nutrition support, +/- jejunal tube feeding if participant chooses) delivered via telehealth. For those randomised to intervention group, participants will receive the active intervention for 6-months, commencing as soon as possible after diagnosis. Personalised nutrition support/advice will be provided. Outcomes will be measured at baseline and at follow up at 3 and 6 months. It is hypothesised that this study will demonstrate effectiveness of early and frequent dietetic intervention and supplemental jejunal feeding (when required), in enhancing quality of life.

This is a combined drug treatment arm within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. The combination of gilteritinib and venetoclax will be evaluated for its activity in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details: The trial will commence with a safety run to determine the optimal dosing. Gilteritinib is given orally with or without food. Venetoclax is given orally after food. Venetoclax dose ramp-up is required only for patients commencing therapy with bone marrow blasts of greater than or equal to 5%. Each cycle will be 28-days in length Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Gilteritinib and Venetoclax will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The headset has in-built sensors that are able to track the movements of surgeons. There are specific patterns of movement that are associated with increased expertise. It is based on these specific patterns of movement that we aim to utilise to objectively assess surgeons. The project will involve surgical registrars and consultants performing operations as they normally would whilst wearing the motion-tracking headset. A transition to the operating theatre will allow us to further identify whether this headset can be used in a clinical environment and continue to provide objective assessment data. We aim to video tape the procedures to allow for further post-hoc analysis of the footage. We hope to use a headset that can tell us how efficiently a surgeon performs an operation to allow us to improve how we assess surgeons. We aim to use this technology to improve the surgical educational landscape by creating an objective method of assessing surgeons.

This multi-centre, prospective, tele-trial enabled interrupted time series trial will assess the feasibility, acceptability, and impact of pre-emptive, broad panel, pharmacogenomics testing and prescribing in patients with cancer commencing systemic anticancer treatment. This trial also aims to identify new pharmacogenomic dosing algorithms for medicines commonly used in the treatment or supportive care of cancer, and new pharmacogenomic variants associated with medication response or toxicity. Who is it for? You may be eligible to join this study if you are aged 18 years and older, are planning to receive systemic anticancer treatment, and have a diagnosis of gastrointestinal, breast or head & neck cancer, or diagnosis of Cancer of Unknown Primary, Hodgkin’s lymphoma or Non-Hodgkin’s Lymphoma. Study details Participants will be allocated to the intervention group or the control group depending on when they enter the study. All participants will undergo standard and discovery pharmacogenomic panel testing. Standard panel test results and dosing recommendations (based on panel results) will be provided to all participants and their clinician before commencement of anticancer treatment. Participants in the control group will receive dosing recommendations for Fluorouracil and Irinotecan. Participants in the intervention group will receive dosing recommendations for Fluorouracil, Irinotecan, and other commonly used medicines in the treatment or supportive care of cancer. If participants are receiving treatment with a ‘medicine of interest’ (i.e. netupitant/palonosetron, esomeprazole, morphine, oxycodone, fentanyl, irinotecan or sacituzumab govitecan), they may be eligible to participate in optional pharmacokinetic substudies assessing the relationship between medication exposure/response and pharmacogenomic variants. Participants will be followed up 5 times over a 12-week period. The first visit will occur within 30 days of commencement of anticancer treatment. Subsequent visits will occur 1 week, 4 weeks, 8 weeks and 12 weeks after anticancer treatment commencement. At each follow up visit, participants will complete questionnaires regarding symptom burden/toxicity and quality of life. The pharmacogenomics pharmacist will also take a medication history, assess symptom burden/toxicity, and provide advice on managing side effects from anticancer treatment. Participants who choose to participate in pharmacokinetic substudies will be asked to provide blood samples before and/or after medication dosing. It is hoped that this research project will show whether pre-emptive, broad panel pharmacogenomic testing and prescribing reduces adverse medicine events from medications commonly used in the treatment or supportive care of cancer. We hope to demonstrate that the pharmacogenomics testing and prescribing is feasible, acceptable and cost-effective within the Australian cancer care setting.

This multi-centre, prospective, tele-trial aims to evaluate the safety and efficacy of 5-Fluorouracil (5-FU) Therapeutic Drug Monitoring (TDM) in patients with metastatic/unresectable colorectal cancer. This trial will also assess the feasibility and acceptability of participants to conduct 'at-home' TDM self-testing. Who is it for? You may be eligible to join this study if you are aged 18 years and older, and are planning to commence infusional 5-FU-based chemotherapy that is used first-line or subsequent line (if being treated with irinotecan for the first time) for metastatic/unresectable colorectal cancer. Study details This is a sub-study of the PRECISION-ITS trial, all participants in this substudy will also participate in the primary PRECISION-ITS trial. In this substudy, patients will receive combined pharmacogenomics and TDM prescribing for 5-FU. Pharmacogenomic test results and dosing recommendations (based on panel results) will be provided to all participants and their clinician before commencement of chemotherapy. TDM test results and dosing recommendations will be reported by the pharmacogenomics pharmacist to the participant's clinician(s) in real-time before the next chemotherapy cycle. TDM will commence from the first cycle of chemotherapy and continue at consecutive chemotherapy cycles until target 5-FU drug levels are reached. At each chemotherapy cycle requiring TDM, participants will be asked to provide blood samples 3-17 hours and 18-40 hours after commencement of infusional 5-FU. The first sample will be self-collected by participants via finger prick blood collection devices, The second sample (consisting of finger prick and venous blood samples) will be collected by site staff. Participants will receive education from the pharmacogenomics pharmacist on how to conduct TDM self-testing and sample delivery. It is hoped that this trial will show that a combined pharmacogenomics/TDM prescribing approach for 5-FU increases treatment response to 5-FU based chemotherapy in metastatic/unresectable colorectal cancer, and that 'at-home', finger prick TDM testing by patients is feasible (thereby reducing patient burden for venous blood tests).

There is strong evidence that exercise reduces falls in older people. However, many older people do not do sufficient exercise to reduce their risk of falls. While there are programs and resources to support older people engage in exercise, these have predominantly been developed for people from English speaking backgrounds. The aim of this project is to work with older people from three culturally and linguistically diverse backgrounds to co-design an exercise and fall prevention program. The program will include specific strategies to support behaviour change and development of exercise habits, resources for older people from the three culturally and linguistically diverse groups and a training package/resources for health professionals. Key components of the developed intervention will be tested with 10 older adults from Italian, Chinese and Arabic speaking communities.

This study will investigate the effectiveness of two interventions to prevent surgical site infection after below-knee surgery for skin cancer in adults. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a skin cancer below the knee which requires a complex surgical technique (flap or graft repair), and you are a patient at one of the participating centres in Queensland. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. Participants allocated to the first group will be asked to take an oral tablet pre- and post-surgery, and use an antibacterial body wash prior to their surgery. Participants allocated to the second group will also be asked to take a pre- and post-surgery antibiotic dose and use a provided body wash prior to their surgery. Participants allocated to the third group will be asked to take an oral tablet pre- and post-surgery and use a provided body wash prior to their surgery. It is hoped this research will determine whether use of oral antibiotics with or without antibacterial body wash has any impact on the incidence of post-surgical skin infections in patients undergoing surgical removal of below the knee skin cancers. If one or both of these measures is found to be effective, a larger trial enrolling a greater number of participants may be undertaken.

This study is designed to evaluate the safety and tolerability of arginine undecylenate (15% w/w undecylenic acid) and to explore its effectiveness in mitigating the pain associated with the lesions that present as a result of VZV infection (shingles). Up to a total of 30 eligible participants will be randomly assigned in a ratio of 2:1 to apply either arginine undecylenate (n=20) or placebo (n=10) to their shingles lesions twice daily for 10 consecutive days. The Zoster Brief Pain Inventory (ZPBI) will be completed by the participant throughout the study. Participants will return to the clinic on Day 5, Day 11, and Day 30 for safety review and preliminary efficacy assessments.

The study aims to investigate the impact of legume consumption on mood. It is a 4 week randomized controlled trial where three meals per week are provided to the participants. The meals will be matched for macronutrient content between the control and intervention groups. The primary endpoint is understanding change in mood due to legume consumption. Secondary measures will consider impact of legume consumption on gastrointestinal symptoms, diet and sleep quality and physical activity. All study visits will be conducted at the nutrition teaching laboratory at the University of Canberra.

To assess current management, including adherence to national guidelines, and outcomes in patients with intracranial haemorrhage. To also improve adherence to guidelines through the use of an integrated continuous Quality Improvement program assessing key performance indicators of blood pressure control and reversal of anticoagulant medications.