ANZCTR search results

It is not known when in the course of incurable cancer referral to a specialist palliative care service should optimally be made. It is hypothesised that early contact with palliative care services will improve patients' end of life experiences through better symptom control and quality of life; addressing patients' supportive care needs; reducing lines of chemotherapy, and reducing the likelihood of dying in the acute hospital setting.

This study involves treatment with a standard chemotherapy for melanoma in combination with immune therapy. Fotemustine is a chemotherapy drug that is approved for use in metastatic melanoma. It has been shown to produce responses in 15 % of patients. Other benefits include delaying the onset of metastases to the brain, with its major side effects including nausea and vomiting (generally well controlled with current anti-nausea treatments) and low blood counts that could lead to a risk of bleeding and/or infections. The main aim of the study is to determine the number of patients who respond to successive treatment with chemotherapy followed by vaccine therapy and Ipilimumab in patients with previously untreated stage IV metastatic melanoma. It is planned to include 50 patients with stage IV metastatic melanoma in this study over a 3 year period. Who is it for? You may be eligible for this study if you have metastatic stage IV metastatic melanoma, provide written informed consent , an ECOG performance status of 0, 1 or 2, are deemed by your physician to be able to safely undergo leukapheresis, are aged greater than or equal to 16 years, have a life expectancy estimated to be greater than 4 months, and are able to provide a tumour sample or an alternative source of tumour antigen – as arranged by your treating hospital or facility. Trial Details: There are two components to the immune therapy that the patients will receive. One is treatment with a vaccine comprised of the patients’ own Dendritic Cells (immune system boosters, also known as DC’s), treated in the laboratory with their own tumour (autologous melanoma), plus a number of agents known to help stimulate the immune system. Previous studies have shown response rates (meaning melanoma shrinkage) in 10-25 % of cases at best. The overall survival benefits have not been assessed in large numbers of patients. However in a small trial of 11 patients receiving vaccines similar to (but not identical to) the vaccine being used in this study, 3 remain alive 5 years after study enrolment. The second component of the immune therapy is an antibody (Ipilimumab) that unblocks the protective mechanisms that normally operate to prevent the immune system recognising and damaging one’s own body. With this protective mechanism in place, it is very difficult for vaccines to boost the immune system to recognise and kill the melanoma. Ipilimumab has been shown to prolong survival in patients with metastatic melanoma who have previously failed chemotherapy. Of patients previously treated with chemotherapy and then treated with Ipilimumab, 44% were still alive one year after starting Ipilimumab treatment. In comparison of the patients who did not receive Ipilimumab only 25% were still alive after one year. By combining a vaccine with Ipilimumab, it is expected that the boosted immune system (resulting from the vaccines) will not be prevented from recognising and killing the melanoma.

Handwriting performance is often impaired after a stroke. Although task-specific upper limb practice can improve outcomes, the effectiveness of adult handwriting retraining has not been investigated. The aim of this study is to test the feasibility of a 4-week retraining program to improve handwriting performance using a pilot randomised trial design. Concealed allocation, blinded assessors and intention to treat analysis will be used. A community sample of 20 people with stroke will be randomly allocated to receive either 4 weeks of tailored handwriting retraining with twice weekly coaching sessions at home, or usual care. Outcomes will be obtained by a blinded assessor at baseline, and 4 weeks and 3 months post-intervention.

The study will examine the possibility that dendritic cell immunotherapy might increase HCV-specific cell mediated immunity with a concomitant decrease in the viral load, or even viral clearance.

People with type 2 diabetes have both greater risk of heart attack and are likely to be resistant to drugs such as aspirin commonly used to prevent heart attacks. Furthermore, while some clinicians currently change drug therapy or increase the dose given to people with diabetes, no studies have been done to assess the risk or benefit of such action and there is a need for clear, evidence based, clinical guidelines to be established. Therefore we aim to pilot a study which will assess the effect of increasing frequency of aspirin dosing, adding alternative drug therapy, or better management of hyperglycaemia to improve markers of heart attack risk. We hypothesize that these approaches will improve markers of platelet activation in aspirin resistant diabetics.

We propose to measure Vitamin D levels in a group of patients attending the Fremantle Dermatology clinic pre and post UVB and UVA phothterapy, to see whether there is any change in the levels post phototherapy.

The aim of this study is to assess the local tolerability of an experimental ointment called AN2728. This ointment has been tested in 11 clinical trials to date, and is being developed as a treatment for patients with psoriasis. In the laboratory this ointment has been shown to reduce inflammatory chemicals in the body that are involved in inflammatory skin diseases. This study will help doctors find out how well people will tolerate the application of the ointment to sensitive areas in terms of any local reaction (ie. irritation, redness, itchiness). Participant's skin will be monitored closely at various times throughout the study to assess any effect that the drug has on their skin.

The primary aim of the study is to determine the effect of maternal dietary supplementation with n-3 LCPUFA in pregnancy on the percentage body fat in children at 3 and 5 years of age. the pathway to obesity begins early in life, and reducing this early accumulation of excess body fat represents an essential strategy for improving health outcomes across the life course.

We have chosen two established antenatal education programmes (‘SheBirths’ and 'Acubirth'), which together introduce 6 different CM techniques for the management of labour and birth. We plan to introduce the programme via 10 two-day workshop to 96 women and their birth partners over a period of 12 months. We will adapt the programme for implementation at 2 large teaching hospitals in NSW. Participants and their birth partners will be recruited from Antenatal clinics from 24 weeks of gestation and randomly allocated to attend the CM birth education program plus standard care or to standard care alone. The CM birth education programme is an intervention which introduces techniques of: Physiology of birth, the Fear-Pain-Tension cycle; Movement and positions for birth; Acupressure techniques; Guided visualisation; Breathing techniques. Outcomes: The primary outcome to be evaluated is the rate of epidural use. Secondary outcomes to be evaluated include: pharmacological pain relief, instrumental delivery; caesarean section; length of labour; Apgar scores; admission to NICU/SCN; gestational age at delivery; satisfaction/control scores and post-natal depression scores.

The primary aim is to determine whether supplementing pregnant women with DHA-rich capsules from 18-21 weeks of prengnacy until delivery will enhance the general cognitive ability of children at 4 years of age. Hypothesis: Children whose mothers took DHA-rich fish oil capsules during the second half of pregnancy will have enhanced cognitive development at 4 years of age compared with children whose mothers consumed a placebo. This will be investigated using psychometric assessments.