ANZCTR search results

The purpose of this study is to test if a chemical called prochlorperazine (Stemetil) can move the target of a chemotherapy drug called cetuximab to the surface of cancer cells. Who is it for? You may be eligible for this study of you are aged 18 or over and have a squamous cell carcinoma of head and neck which is amenable to biopsy Study details All participants in this study will have a small biopsy of their tumour then an infusion of the study drug (prochlorperazine) through a needle in their arm 60-90 minutes before another biopsy of their tumour. The biopsy sample will be analysed in a laboratory to see the effect of the drug on a receptor on the surface of cancer cells. It is hoped this research will demonstrate that prochlorperazine makes cancer cells more sensitive to the chemotherapy drug cetuximab.

This project seeks to determine the feasibility and effectiveness of timing exercise to control blood glucose levels and reduce cardiovascular risk in people with Type 2 Diabetes. People with Type 2 Diabetes will be randomised to standard care alone or with time of exercise specified to coincide with/avoid blood glucose peak. It is hypothesised that individually prescribing ‘the time’ a person should exercise will optimised blood glucose control and attenuate peak blood glucose when compared to standard care and exercise at times other than peak.

Women with Gestational Diabetes (GDM) are recommended to monitor their blood glucose levels (BGLs) aiming at tight control to improve the risk of adverse outcomes. After initial review, our service undertakes weekly phone or email contact with women for surveillance of glycaemia. This creates a significant treatment burden for the patient and clinician. We are investigating the use of the Net-Health mobile phone application (app) and linked glucose meter, as part of a blood glucose management system in women with GDM. This app: 1) Automatically uploads BGLs in real time to a secure server for review remotely by the treating team; 2) Automatically generates an email alert to the treating team if BGLs are out of target range; 3) Allows messaging via the app for dose titration if required. We plan to undertake a pilot study of 100 women, recruited from our GDM group education session. Data will be collected to assess feasibility, patient satisfaction and resource utilisation. We will also gather data to explore patterns of glycaemia, maternal and neonatal outcomes. We hypothesize this management system will be feasible and will lead to a more efficient and responsive model of care and use of resources.

This study aims to evaluate the long term cardiovascular risk factors associated with taking endocrine therapies in patients with oestrogen receptor positive breast cancer. Who is it for? You may be eligible to join this study if you are aged 50-85 years (post-menopausal) and going to commence endocrine therapy treatment for breast cancer for at least 12 months, Study details The study will run for 12 months to observe the potential effects of endocrine treatment on cardiovascular risk factors. The study will involve 3 visits to determine changes in body fat distribution, and other markers of cardiovascular health. Part of the study will involve questionnaires, fasting blood tests, body, liver and bone density scans, There will be an additional blood test done between visits 1 and 3. The results of this study will provide clinicians with a potential means of stratifying each breast cancer woman's cardiovascular risk, enabling delivery of personalised care. This project will also provide a platform for subsequent interventional studies to investigate the clinical impact of risk factor modification.

The study aims to determine whether it is feasible to deliver a particular diet and exercise program for people with hip osteoarthritis who are overweight or obese. We hypothesise that it is feasible to deliver such an intervention.

This study aims to develop a multi-marker assay that will serve as a diagnostic blood test for the detection of early stage melanoma skin cancer (cutaneous melanoma). Who is it for? You may be eligible to join this study if you are aged 18 years or older and have an abnormal skin lesion thought to be melanoma or other types on non-melanoma skin cancer. You must be willing to provide a blood sample prior to your routine skin biopsy. You may additionally be able to participate if you have recently been diagnosed with other types of cancer (early stages) or an autoimmune disease. Study details This study will involve taking a blood sample with a needle from your arm prior to the routine biopsy of your skin lesion. This blood sample will be tested for specific antibodies related to melanoma. The results of this blood test will be compared to results of the biopsy in order to determine how accurate it is at detecting melanoma. It is hoped that this blood test can be used to provide greater diagnostic certainty prior to biopsy and for routine screening of people who are at a higher risk of melanoma.

Severe aplastic anaemia is a rare disease where current standard upfront treatment is immunosuppressive therapy (IST) in those ineligible for haematopoietic stem cell transplant (HSCT). Approximately 20% of patients with severe AA are refractory to IST and another third of patients will relapse within two years. Partial or no response to IST leaves patients at ongoing risk of life-threatening complications of AA such as, infections, haemorrhage and patients will require ongoing supportive treatments such as antibiotics, red blood cell and platelet transfusions, to combat these complications. Eltrombopag is a thrombopoietin (TPO) mimetic and has shown promising efficacy for severe AA in phase II trials. Avatrombopag is a second generation TPO mimetic which has been studied in immune thrombocytopenia and thrombocytopenia due to chronic liver disease. It has several potential advantages over eltrombopag, including dosing, lack of toxicities, pharmacokinetics and potential increased potency. Avatrombopag has not been tested in AA to date. In this study, avatrombopag will be given to severe AA patients relapsed or refractory to IST to determine if the rate of production of platelets, red blood cells and white blood cells is increased.

Severe aplastic anaemia is a rare disease where current standard upfront treatment for patients ineligible for haematopoietic stem cell transplant (HSCT) is immunosuppressive therapy (IST). Although patients with severe AA treated with IST (horse antithymocyte globulin [ATG] and CyA) have overall responses reported in 50-75%, the minority achieve complete responses, approximately 20% are refractory to IST and approximately 30% will relapse by 2 years. Partial or no response to IST leaves patients at ongoing risk of life-threatening complications of AA such as infections, haemorrhage and patients will require ongoing supportive treatments such as antibiotics, red blood cell and platelet transfusions, to combat these complications. Eltrombopag is a thrombopoietin (TPO) mimetic and has shown promising efficacy for severe AA in phase II trials. Avatrombopag is a second generation TPO mimetic which has been studied in immune thrombocytopenia and thrombocytopenia due to chronic liver disease. It has several potential advantages over eltrombopag, including dosing, lack of toxicities, pharmacokinetics and potential increased potency. Avatrombopag has not been tested in AA to date. In this study, avatrombopag will be given in addition to standard IST to treatment naive severe AA patients to determine if the rate of production of platelets, red blood cells and white blood cells is increased.

This study aims to evaluation of The Chinese Herbal Medicine (T50) as Add-on Treatment to Metformin Monotherapy in Participants with Type 2 Diabetes Mellitus: A 12-week randomised, double-blind, placebo-controlled pilot clinical trialParticipants will be male or female, aged greater than or equal to 18 years, with type 2 diabetes treated with metformin as monotherapy and with suboptimal glycaemic control as evidenced by a glycosylated haemoglobin (HbA1c) level between 7% and 9%. Participants will be recruited from a large GP centre in Sydney. Awareness of the study will be via the University of Technology Sydney website, and by advertising in the Medical Centre. Study Drugs: T50 (a sachet formulation of Chinese herbal extracts)

Research Aims: To determine the clinical effectiveness of the Epley manoeuvre versus the somersault manoeuvre using a multi-axial repositioning device (Epley Omniax Machine) for the treatment of posterior canal Benign Paroxysmal Positional Vertigo (BPPV). This will be a randomised controlled trial. Participants: ~100 participants with Posterior canal Benign Paroxysmal Positional Vertigo Methods: Participants will be recruited from The Royal Victorian Eye and Ear Hospital Balance Disorders and Ataxia Clinic from those referred to the Epley Omniax for repositioning treatment of BPPV. For those determined to have posterior canal BPPV, they will be randomly assigned to one of two treatment groups being either the Epley manoeuvre, or the Somersault manoeuvre. A maximum of four treatments will be performed before removing from the trial. Patients will receive the alternative treatment if the experimental treatment is not successful. Treatment success is determined by resolution of nystagmus and symptoms on re-assessment. Expected outcomes: It is anticipated the somersault manoeuvre could be more clinically effective than the Epley manoeuvre for the treatment of BPPV, particularly in the case of refractory presentations.