ANZCTR search results

This trial (MONARCC) seeks to determine what the best initial treatment is for a patient population with metastatic colorectal cancer that cannot withstand the expected side effects of the commonly used combination chemotherapy regimens. Who is it for? You may be eligible to join this study if you are aged 70 years or above and have a confirmed diagnosis of untreated metastatic colorectal cancer. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive low intensity targeted therapy, panitumumab, which is generally well tolerated as a single treatment without chemotherapy. Participants in the other group will receive panitumumab combined with chemotherapy (5FU), a standard treatment. All treatments are administered via the intravenous route (i.e. directly into the vein) and will be administered every 2 weeks until disease progression or unacceptable toxicity. All participants will be followed up to 18 months in order to assess treatment efficacy and safety. The hypothesis is that panitumumab will be a safe, acceptable, effective and convenient regimen to elderly patients with newly diagnosed advanced colorectal cancer.

This study aims to determine if ibudilast, an anti-inflammatory drug, can prevent acute neurotoxicity and chemotherapy induced peripheral neuropathy. Who is it for? You may be eligible if you are over 18 years old, have been diagnosed with metastatic gastrointestinal cancer and have at least two cycles of chemotherapy with oxaliplatin planned. Study details Participants will be required to take the study drug, twice a day, for one cycle of chemotherapy treatment (2-3 weeks depending on the length of the chemotherapy cycle). Participants will also be observed for one cycle of chemotherapy treatment. Participants will also need to complete questionnaires, take blood tests and complete a physical assessment with a clinician. This will occur at the beginning of the study, during the chemotherapy cycles and one more time 3 months later. This study will help to inform research into minimising side effects for patients while undergoing chemotherapy.

This is a prospective study of individuals who have acquired spinal cord injury. Part 1 is a prospective study that will identify risk factors associated with the development of a sitting acquired pressure injuries (SAPi) in acute and chronic cohorts with SCI. Part 2 will assess individuals who develop a SAPU to measure the loss of health related quality of life and to quantify the costs of treating their SAPi. Subjects will be recruited from 6 sites – 3 state spinal cord injury units in Australia and 3 in Canada and it is intended that 480 subjects will complete the study. 240 will be acute (first 3 years post SCI) and 240 will be chronic (more than 15 years post SCI). Both cohorts will be followed and 9 Risk Factor Groups will be measured – degree of impairment/activity limitation, nutritional status, local tissue status including cutting edge ultrasound and Finite Element Modelling, wheelchair seating environment, psychological factors, co-morbidities, injury duration and country. Those factors that are significantly associated with the development of a pressure injury will be identified through Logistic regression modelling and a risk assessment tool will be derived.

Knee stiffness is treated using exercise and manual therapy. Manual therapy techniques utilize accessory movements to increase the range of movement of joints. The accessory movements aim to replicate those that occur during the normal joint movement. In order to increase knee flexion, the accessory movement is a posterior glide achieved by applying pressure to the top of the tibia in an anterior to posterior direction. This is based on the concave/convex rule which is applied to all joints. However, recent 4D in vivo kinematic modelling conducted by our group indicates that posterior to anterior pressures better replicate knee joint movement at the end of flexion. The aim of this study is to compare the results of both techniques in patients presenting with stiff knees. The aim of this as a pilot study, is to explore the feasibility of running this study, as well as collect data on effect size, responsiveness to intervention, and information on dose-response to inform a later clinical trial. The primary outcome is change in knee flexion range and secondary outcomes include measures of pain and function. The clinical significance of this project is to change practice in physiotherapy to ensure the most effective manual therapy techniques will be used to restore movement and relieving pain.

The READY study is a double-blinded randomised controlled trial with two parallel arms. A 2 week web-based employee decision aid tool and a control website. Participants will have open access to the website for 2 weeks, this is to assist the participants in being able to make a decision by understanding that the decision aid tool will come to an end at the 2 week period with an expectation of a decision to be made at this point as informed in the PIS. Assessments will occur at baseline, post-intervention (immediately after intervention) and follow-up 6 weeks post-intervention.

In Australia cashew nut allergy is the most common of the tree nut allergies in adolescents. The 2016 revised Australasian Society of Clinical Immunology and Allergy (ASCIA) infant feeding and allergy prevention guidelines recommend: all infants should be given allergenic foods including peanut butter, cooked egg, dairy and wheat in the first year of life. However there is no specific mention of tree nut foods, like cashew nut spread. This is because we still need to establish evidence of the effect of regularly eating tree nuts or tree nut spreads in early childhood as a tree nut allergy prevention strategy. Cashew nut spreads are now readily available in supermarkets. With the texture of a paste like peanut butter, they could feasibly be introduced into the diets of infants once they have established the developmental readiness for eating solid foods. We propose to investigate two different doses of cashew nut spread regularly eaten by infants from 6 months of age onwards. This study will enable us to examine whether babies regularly eating cashew nut spread should be further investigated as a cashew nut allergy prevention strategy in a larger multi-centre randomised controlled trial. This evidence will contribute towards providing specific recommendations to also include tree nut spreads introduction during infancy in allergy prevention guidelines.

Obstructive sleep apnoea (OSA) is increasingly recognized to be a risk factor for cardiovascular disease. Case reports have shown that these patients can manifest as suspected angina with no obstructive coronary artery disease (NOCAD). Recently, this condition has been demonstrated to be associated with coronary microvascular dysfunction and vasospastic angina in the Chinese and Japanese population. This association is unknown in the Australian population. The underlying mechanism remains poorly understood and appropriate therapies are limited. We will examine the relationship between symptomatic angina with NOCAD and OSA. The planned projects will provide more insights into the relationship between OSA and coronary/peripheral haemodynamics as well as whether therapy for OSA impacts on the angina burden.

The aim of this project is to compare the effects of an exercise program compared to usual care on cancer progression in men with low-risk prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer. Study details This study will be conducted over 3 years. Participants will be randomised to either an exercise intervention or a usual care intervention. Participants who are randomised to the exercise intervention will take part in the following five stages of exercise intervention: - Stage 1: will consist of supervised resistance and aerobic exercise 3 times a week for 6 months. - Stage 2: Exercise sessions will be decreased to once a week for months 7 and 8. - Stage 3: Exercise sessions will decrease to 1 session every 2 weeks for months 9-10. - Stage 4: Exercise sessions will decrease to once a month for months 11-12 - Stage 5: Participants will be provided with support to continue their exercise program using local exercise facilities and encouraged to self-manage their exercise routine from months 13-36. Usual care participants will take part in a walking program and be provided with information on physical activity recommendations. All participants will be required to complete 4 follow up assessments at 6, 12, 24 and 36 months involving questionnaires, blood tests and other general health checks. This study will provide information on the potential benefits of exercise in delaying the progression of prostate cancer.

Background: Knee pain is the second most common musculoskeletal complaint, second only to back pain. Both education and physiotherapist led exercise have been reported to be effective. However, to date, there is little research evaluating the effectiveness of education alone, and how many people still need physiotherapy following receiving appropriate education. Population: 30 young people (18 - 40y/o) with knee pain. Outcome measures: Pain, function, muscle strength, movement pattern, psychosocial factors, knowledge and quality of life. Phase 1 intervention: 6 weeks of online and leaflet based self-directed education to teach how to manage pain including strategies and importance of exercises to improve pain. All outcome measures will be reassessed following the 6 week period. Phase 2: Those who do not rate themselves as completely recovered following phase 1 will receive further 12 weeks tailored education and exercise guidance from a physiotherapist. This treatment will be randomly provided via 1 of 2 protocols: (i) 8 sessions of one on one physiotherapy to allow progression of exercise into a gym program; or (ii) 8 sessions of physiotherapy delivered via Skype to guide home exercises and educate them about their condition. Both groups will be reassessed for all outcome measures at the completion of this 12 week period.

Simulation training is used to develop both clinical and teamwork skills. Effective teamwork, including allocation of leadership is an important factor in providing high quality patient care in emergencies. This project aims to evaluate how maternity teams share leadership and during emergencies and determine if leadership sharing is related to teamwork and clinical performance.