ANZCTR search results

This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2). Who is it for? You may be eligible to join this study if you are aged 18 years or above and are either: a) men or women with confirmed evidence of metastatic triple negative breast cancer OR b) women with confirmed evidence of relapsed high grade serous ovarian cancer or high grade endometrioid ovarian cancer Study details All study participants will take olaparib 300 mg orally twice daily until disease progression or unacceptable toxicity. Assessments for safety and efficacy will be followed up for a minimum of 6 months Olaparib, has been approved overseas and in Australia in women shown to have inherited changes in their BRCA1 or 2 genes. There is strong evidence to show that olaparib will also work in people who do not have any changes in their genes. The purpose of this study is to assess whether the olaparib is effective in treating these tumours.

Idiopathic Pulmonary Fibrosis (IPF) is a debilitating, progressive lung disease with poor prognosis and limited current treatment. It is characterised by distorted lung architecture, loss of respiratory function, poor quality of life and unresolved pathogenesis. In 2014, the FDA and TGA approved the first two oral drugs for the treatment of IPF, however they only slow the progression of IPF. As such, there continues to be a need for a more effective treatment method for this fatal disease. To address this need, Samumed has developed a small molecule inhibitor of the Wnt pathway, SM04646. Studies have suggested that dysregulation of the Wnt/b-catenin pathway is associated with the pathophysiology of IPF. A number of preclinical pharmacology efficacy studies have been carried out which indicate that SM04646 blocks the progression of lung fibrosis in animal models of IPF. A Phase I study has also been conducted recently in Australia using single ascending doses (SAD) of SM04646 in healthy volunteers. No dose limiting toxicities or serious adverse events were reported. The current study is a Phase I open label, multiple ascending-dose (MAD) safety study of SM04646 inhalation solution in subjects with mild to moderate IPF. SM04646 will be administered as a single use nebulised inhalation. Dose levels will be 2.0mg, 7.0mg, and 20.0mg. Subjects will be treated for 28 consecutive daily doses and will be followed for approximately 30 days after last treatment. Samumed is conducting this trial to evaluate the safety, tolerability and systemic exposure of SM04646 Inhalation solution in IPF patients. Safety monitoring throughout the study will allow for the estimation of the maximum recommended dose to be used for future studies conducted with individuals with IPF

Knee osteoarthritis is a common condition that affects the cartilage lining of the knee joint and causes pain and stiffness. It is therefore important to find effective treatments that improve people’s symptoms and quality of life, and also slow down the loss of joint cartilage that happens in osteoarthritis. One such therapy that may be effective is platelet-rich plasma (PRP) injections. This treatment involves an injection of the person’s own PRP, which is made from blood taken from their arm and injected into their knee. Blood contains plasma, red blood cells, white blood cells and platelets that release chemicals which can stimulate the healing process. This may give rise to improvements in symptoms and slowing of the disease process. This study aims to find out whether a series of three PRP injections (one per week for three weeks) into the knee joint is effective in reducing pain and slowing loss of cartilage in the knee joint. To do this, we will compare outcomes over 12 months in a group of patients with knee osteoarthritis who receive three PRP injections and a group who receive three injections of inactive sterile salt injections (saline). We will recruit 288 people with mild to moderately severe knee osteoarthritis from the community. Measurements will be taken at baseline, 2 months and 12 months and will comprise questionnaires and magnetic resonance imaging. Participants will be randomly allocated to either the PRP or saline injection group and neither the participant, nor the injecting doctor or the assessor will know which injection the participant will receive.

The current study aims to investigate the effect of using warm and humidified carbon dioxide (CO2) gas instead of cold dry CO2 (standard of care) during laparoscopic surgery, and the insufflation of warmed humidified CO2 during open abdominal surgery, The Study will be a single blinded randomized controlled study and participants will be recruited from patients undertaking laparoscopic or open abdominal surgery. Primary outcome will be the effect of using warm humidified CO2 insufflation gas on body temperature with histopathological changes to the peritoneum and post-operative pain being measured as secondary outcomes. Clinical benefit will be assessed by measuring post-operative pain, using a post-operative pain questionnaire, temperature to assess for hypothermia and analyses of peritoneal biopsies taken at the beginning and just prior to conclusion of the operations. It is expected that warm and humidified CO2 will reduce hypothermia and peritoneal damage, and improve post-operative pain.

Smoking prevalence amongst people with alcohol and other drug (AOD) problems is extremely high. In Australia, up to 95% of people entering AOD treatment smoke tobacco, which is five times greater than for the general adult population. Although number of quit attempts are high, sustaining cessation is challenging for people with AOD dependence: many factors related to addiction, lack of cessation support and the high levels of smoking in their social network contribute to high relapse rates in this population. Nicotine Replacement Therapy (NRT) can reduce withdrawal symptoms and cravings and aid cessation, however our research with AOD users indicate they are hesitant to use traditional forms of NRT. Electronic Nicotine Devices (ENDs) hold significant potential as both cessation aids and harm reduction support. Unlike combustible tobacco cigarettes, ENDs deliver nicotine in an inhalable form without the tobacco, hence removing many of the health harms of smoking. This proposal is for a trial aimed at exploring the feasibility, acceptability and potential effectiveness of providing an Electronic Nicotine Device (END) kit, a 12 week supply of liquid nicotine and Quitline support compared with a 12 week supply of combination nicotine replacement therapy and Quitline support to clients upon discharge from an AOD residential withdrawal clinic. The clinic is smoke-free and all clients who smoke tobacco receive NRT while in the program but not following discharge. The trial provides an opportunity to continue cessation support to clients in the community. Specifically, this trial aims to determine whether providing ENDs or combination NRT to AOD clients: assists them to quit smoking following discharge from a smokefree facility, reduces tobacco consumption by at least 50% compared to pre-AOD treatment levels in those who relapse, reduces cigarette (tobacco and/or electronic) cravings and withdrawal symptoms, and demonstrates that ENDs are more acceptable than combination NRT as a quit aid and/or method of harm minimisation. The trial also aims to determine the acceptability of proactive Quitline calls prior to and post discharge from a smoke free AOD facility. A pragmatic pilot randomised trial will be conducted. In addition participants will be asked to provide consent to contact to be possibly be invited at the end of the trial to participate in a one-off qualitative telephone interview to explore participant study experiences.

Total Hip Arthroplasty (THA) is a recognised treatment in Australia and internationally for people with disabling, painful hips. THA patients participate in number of models of rehabilitation, including; inpatient, outpatient and domiciliary programmes. To date there is no definitive evidence to support one model over another. Inpatient rehabilitation is far costlier than outpatient or domiciliary programmes. If the cost is to be justified we argue that the functional outcomes from inpatient rehabilitation should be superior to alternative programmes. HIHO 2 aims to compare the functional outcomes of individuals who undergo THA and then receive inpatient rehabilitation plus a home-based programme with individuals who receive a home-based programme alone (standard treatment). Eligible participants are people undergoing a planned, hip replacement, on one side (first time on that side). They must be able to read English and follow instructions for hospital and home-based programmes. Those who are eligible but decline randomisation will be asked to join the observational arm which receives a home-based programme (standard treatment). HO-Group (Home-based) - 2 -5 days after surgery a physiotherapist will instruct the participants on exercises to be preformed, unsupervised at home. The participants will attend group exercise sessions in the local outpatient department. On their first visit, 3 weeks after surgery, they will rehearse exercises to perform at home and receive a personalised instruction booklet. They will attend 1 or 2 sessions to advance the exercises tailored to their individual needs. The participants continue to preform the exercises at home, between group sessions. The last session is at 10 weeks after surgery. HI - Group (Hospital Inpatient followed by home-based) - individuals will be admitted to Braeside Hospital Rehabilitation Ward for 10 days of inpatient multidisciplinary rehabilitation comprising of 2-3 hours of individual and group based exercises per day. After leaving the rehabilitation hospital, these participants will follow the home-based programme as outlined above. The baseline characteristics recorded pre-operatively are ; age, gender, height, weight, other health problems and education level. The main outcome is the distance walked in six minutes, 26 weeks after surgery. Secondary outcomes will be patient reports of function, pain, quality of life, patient preference for and satisfaction with the type of rehabilitation, satisfaction with surgical outcome and their perceived change in distance walked. Measurements will be taken prior to surgery and at 3, 10, 26 and 52 weeks after surgery. Nested studies will examine the minimal important change for the 6MWT and the parameters of a functional mobility tool (IBMAT). The intention is to published these separately to the HIHO 2 study.

The purpose of this sub-study is to assess the effects of high intensity aerobic and resistance training plus psychosocial support on cardiovascular function in men with metastatic castrate-resistant prostate cancer (MCRPC). Who is it for? You may be eligible to participate in this sub-study if you are already enrolled in the GAP4 INTERVAL clinical trial (ClinicalTrials.gov ID: NCT02730338) in Queensland. Study details In addition to the requirements of the GAP4 INTERVAL clinical trial, all participants in this sub-study will be asked to attend assessment sessions at the University of Queensland at baseline, 3 months, 6 months, 12 months and 24 months after randomisation into the GAP4 INTERVAL trial. At each of these visits, various measures will be taken in order to assess cardiovascular function, including ultrasound and blood tests. The findings of this sub-study will help in developing safe and effective lifestyle interventions which have the potential to lead to improved clinical practice for men with MCRPC.

The effect of hyperinsulinemic euglycaemia (HE) on myocardial ischaemia is unknown. We have previously shown that HE increases myocardial blood flow in healthy individuals. We speculate that following successful revascularisation of a myocardial infarction, HE can improve microvascular flow to both ischaemic and remote non-ischaemic myocardial territories.

Osteoarthritis is a long term degenerative disease process that affects the major joints. Osteoarthritis pain and inflammation is often treated using non-steroidal anti-inflammatory drugs (NSAIDs). In some cases these drugs can be applied through the skin to treat the affected joint below. The skin however provides a significant barrier to drug penetration. Various methods can be used to enhance drug penetration through the skin. In this case the method of enhancement will be by using a low level magnetic field (similar to a fridge magnet). The aim of this study is to evaluate changes in pain and function following short term (48 hours) use of ibuprofen (5%), a topical NSAID, administered in a patch with a magnetic backing strip. The magnetic backing is designed to enhance the absorption of ibuprofen. The ibuprofen patch will be compared to a placebo patch containing no drug and no magnetic backing. The main objective is to determine if the magnetically enhanced ibuprofen patch achieves superior outcomes to placebo in reducing pain and improving function over 48 hours. The primary hypothesis is that the transdermal ibuprofen magnetic patch will result in significantly lower ratings of pain on movement compared to placebo. The pilot study will recruit a group of 24 participants with knee osteoarthritis. Each participant will complete 2, 48 hour study periods. At the start of each study period they will have their current pain and function assessed in a University laboratory. Participants will then have a patch containing either ibuprofen or placebo applied to their knee(s). When this testing has been completed they will be given an iPad which they will use to complete further testing over a 48 hour period as they go about their normal activities while wearing the knee patch. The iPad will prompt them to complete a rating of their pain at rest and pain on movement approximately every 2.5 hours and it will remind them to change the patch approximately every five hours. After 48 hours they will return to the research laboratory and complete the other pain and function tests. After an interval of 1 week all participants will return to the laboratory and complete the full 48 hour testing process while wearing the alternative patch (placebo or ibuprofen). Neither the participants nor the researchers will know on which occasion they received the ibuprofen treatment. It is envisaged that the participants pain levels will be less and their function will be better during the period in which they are wearing the ibuprofen patch. This is a pilot study gathering preliminary data from a relatively small number of participants. The data from the study will be used by the company that has commissioned the research to inform a future large randomised, controlled clinical trial.

A diagnosis of bipolar II disorder is commonly accompanied by a need to make complex treatment decisions about medications and adjunctive psychological therapies, often for lifetime prophylactic (preventative) use. However, people with bipolar II disorder are often reluctant to commence and adhere to effective medications long-term, mostly due to lack of knowledge, less-than-desired involvement and preference for treatments other than those prescribed, which can worsen the course of their illness. Research shows that many people with bipolar II disorder, especially those with a recent diagnosis, prefer a more active role in their treatment decisions than they currently have, and may have greater unmet decision-making needs than those with a longer-standing diagnosis. Yet, there is currently no resource that might facilitate this involvement. This project aims to build on our comprehensive research program targeting bipolar II disorder treatment decision-making by evaluating the world’s first, evidence-based online decision-support resource, a decision-aid website, for patients with bipolar II disorder and their family who are deciding on treatment options for relapse prevention. In this Phase II randomised control trial, a consecutive patient sample (n=60) aged 18+ and with a confirmed clinical diagnosis of bipolar II disorder will be recruited through the Black Dog Institute and randomised (1:1) to receive either usual care with or without the decision-aid. At baseline, immediately post-treatment decision and at 3 months' follow-up, we will assess, via validated and purpose-designed questionnaires, the decision-aid's potential efficacy at improving key aspects of decision-making quality. We expect that the DA will: i) reduce patients' uncertainty and regret in decision-making, ii) empower them to feel more informed and supported in decision-making, iii) help clarify their values regarding for treatment for bipolar II disorder, iv) improve their knowledge about treatment options/outcomes, v) help them to be involved in treatment decision-making to the extent desired, and vi) improve their uptake of effective medication and psychological treatments.