ANZCTR search results

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.

This study aims to assess the effect of positive and negative expectations that develop in response to our daily experience. It is believed that positive expectations increase the benefit from pain program and negative expectations reduce the benefit from the same pain program. Study participants will be asked to fill out a daily questionnaire containing the same seven questions for 28 days when they attend the weekly CALM group program. This will then be assessed against changes in their pain psychometrics before and after the pain program.

Some patients when receiving such mechanical ventilation develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons of such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the reduction in ventilator induced lung injury with the use of ECCO2R device called Prismalung that is currently used in our intensive care unit. This assessment is done by measuring of pulmonary interleukins and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.

This study aims to evaluate the efficacy of Savi Scout® a radar localisation (RL) device in localising non-palpable breast lesion and axillary marking Who is it for? You may be eligible to join this study if you are aged 18 years and older, and have non-palpable breast cancer/breast lesions Study details Participants will be allocated to the intervention group if they consent for participation. Otherwise, they will be allocated to the control group. Participants in the intervention group will undergo RL using the Savi Scout® device to determine tissue margins prior to surgery while the control group will undergo standard of care wire localisation (WL) using Kopans hookwire to determine tissue margins prior to surgery. Participants will be followed-up postoperatively within one month following surgery to assess accuracy of margins, the outcome of a Multidisciplinary Meeting to determine the next step in cancer management. It is hoped that this research project will provide useful information about whether RL is a cost-effective intervention compared to traditional WL.