ANZCTR search results

This is a pilot study looking at the treatment of obstructive sleep apnoea (OSA) in patients with atrial fibrillation (AF), using a mandibular advancement splint (MAS). MAS is an alternative treatment to CPAP (continuous positive airway pressure) therapy, which adheres to the top and bottom dental arches and brings the lower jaw forward, thus preventing upper airway collapse during sleep. There is evidence suggesting that treatment of OSA improves outcomes for patients suffering from AF. This may be particularly true for those patients who have had treatments for their AF such as Cardioversion or Pulmonary Vein isolation. There are no randomised control trials looking at MAS treatment for OSA in AF patients. This pilot study will collect data on patient acceptance, efficacy and compliance of MAS treatment in this patient group. Secondary outcomes include AF recurrence rates, changes in blood pressure, heart rate variability and quality of life questionnaires. Data from this important pilot study will inform a future randomised control trial.

This is a healthy volunteer study to evaluate the safety, tolerability, and pharmacokinetics of a new drug called RT234.

This study aims to determine if patients with cardiac failure and pacemakers are being adequately assessed prior to consideration of listing for cardiac transplant. We hypothesise that by using a treadmill instead of a stationary bike as their functional assessment (cardiopulmonary exercise test) we will generate a higher degree of cardiac function and appropriately delay their transplant listing.

This preliminary survey will determine the baseline characteristics and preferences for prehabilitation in patients schedule for colorectal cancer resection. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with colorectal cancer and scheduled for surgical resection. Study details “Surgical prehabilitation” is the process of making an individual as fit as they can be, before an operation so that they can better tolerate the stress of surgery. Surgical prehabilitation includes exercise, improving nutritional status and psychological counselling with an intention to increase your strength before surgery. Studies have shown that increasing fitness can reduce complications following bowel surgery. We are looking to design a prehabilitation programme for cancer patients at the Prince Charles Hospital. To do that, we would like to know the health condition and fitness levels of the patients. We also want to know your preferences for such a programme. We believe that if we have this information, at a later date, we could design a programme that could be easily followed by the future patients. This is only a preliminary survey

This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced cancer that are androgen receptor (AR) positive. Who is it for? You may be eligible for this study if you have a solid tumour with clinical/radiological progression on or following last anticancer therapy. There study has a focus on, but not exclusive to, rare or neglected cancers. Study details All participants will be screened to confirm if their solid tumour is AR positive by the study team. If eligible, participants will receive the medications of Serivteronel and Dexamethasone (also known as SEVI-D) by oral tablets continuously per cycle (4 weeks). Participants will be asked to have blood tests, scans, complete questionnaire and regularly meet with the study doctor and team. It is hoped this research will demonstrate this treatment could be beneficial for the treatment of cancers that are known to be human androgen receptor positive.

The aim of this study is to test the safety and effectiveness of prostate specific membrane antigen (PSMA) labelled with a radioactive substance called Lutetium-177 (177Lu) in progressive prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a PSMA positive, hormone refractory and progressive prostate cancer. Study details Participants will receive up to six 42-day cycles, with each cycle requiring a single intravenous injection of a radioactive substance called therapeutic 177 Lu-PSMA combined with NOX66. NOX66 is used to make cancer cells more sensitive to radiation treatment and is continued to be given the following 9 days after injection. The exact number of treatment cycles administered and dose given will be determined by the treating doctor. Participants will then be followed for one year after completion of study to assess safety and effectiveness of the intervention. Study rationale Using PSMA labelled molecules enables targeted delivery of high doses radiation to sites of prostate cancer. This treatment is called radionuclide therapy and it aims to minimise radiation of most normal tissue sites. Study Declarations This is a new type of treatment and long-term response and toxicity data are not yet available. The drugs used in this study are not approved by the Therapeutic Goods Administration (TGA) and considered an experimental treatment. This research has been initiated by the study doctor, A/Prof Louise Emmett, and is sponsored by St Vincent’s Hospital Sydney with funding provided by the St Vincent’s Prostate Cancer Centre and Noxopharm Ltd. This will allow you to have the LuPSMA / NOX66 treatment free of charge and for the conduct of the research.

The purpose of this study is to test two different implementation approaches (theory based and non-theory based) in achieving behaviour change amongst healthcare professionals to improve identification of Lynch syndrome amongst colorectal cancer patients. Who is it for? You may be eligible for this study if you are a healthcare professional involved in the Lynch syndrome referral pathway. Although we will be assessing the proportion of colorectal cancer patients appropriately referred for Lynch syndrome genetic testing (based on high-risk LS tumour screening results, e.g. mismatch repair deificiency, or microsatellite instability), we will be targeting the behaviours of health professionals in this study to improve referral practices. Study details Participants will take part in one of two arms (theory based or non-theory based) depending on the hospital in which they work. Participants will be asked to complete questionnaires and will be involved in a series of meetings and focus-groups to map the referral pathway, identify target behaviours for change, identify barriers to behaviour change and develop intervention strategies to address those barriers. Clinical and referral data will be collected before and after the study period to assess for changes in the proportion of patients appropriately referred for Lynch syndrome genetic testing. It is hoped that this research will increase the number of colorectal cancer patients with a high risk of Lynch syndrome who are appropriately referred for genetic counselling and testing.

The primary purpose of this study is to assess the effectiveness of a mobility device, commonly used for rehabilitation in America but not in Australia, for use by Australian adults with declining mobility living in aged care. We hypothesise that this mobility device will have a positive impact on the physical wellbeing of residents living in aged care, relative to mobility training alone.

This is a Phase I, open-label, single arm, safety and tolerability study which will evaluate escalating dose cohorts of ATX-101 to determine the maximum tolerated dose in subjects with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have advanced solid tumours for which conventional anti-tumour treatment has been exhausted or has been refused Study details The study is designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) for ATX-101. Dose escalation will be determined based on recommendations from a Safety Review Committee and is expected to occur over a total of 6 cohorts. Potential study subjects who provide voluntary written informed consent will undergo screening evaluations to determine eligibility within 28 days prior to enrolment and the start of treatment (Day 1). Eligible subjects will be admitted to the study centre on Day 1 for the first dose of study drug to be administered by IV infusion. Prior to each treatment infusion the subject will receive mandated pre-medication. Treatment will be administered weekly in cycles of 21-day duration, with a single IV infusion of ATX-101 on Day 1, 8 and 15. Dosing of subjects will occur weekly for up to two cycles (i.e. 2 x 21 days = 6 weeks), or until criteria for early termination is met. After completion of the end of study visit, subjects without documented progressive disease may be approved to continue weekly treatment under a separate long term follow up protocol (AM ATX101-02). Under Protocol AM ATX-101-02, subjects are to be monitored by tumour imaging every 3 months (± 14 days) until documentation of progressive disease.

Evidence suggests that levels of physical activity tend to decline in older ages and only one in four people over the age of 75 years and over are classified as sufficiently active against Australian national guidelines for physical activity. Our research aims to 1) develop and implement a sustainable exercise program, utilising the recent international recommendations for physical activity for older adults for Australians living in in residential aged care facilities to address physical and psychosocial problems proven to be amenable to exercise; 2) evaluate the acceptability, effectiveness (including cost-effectiveness), sustainability and transferability of the exercise program; and, 3) use the pilot results to develop an application for a NHRMC partnership project. Experimental research design will be used to achieve these aims. This study is a pilot pragmatic non-randomised controlled trial with alongside economic evaluation. Evaluation data will be collected using pre-/post intervention with a comparison group.