ANZCTR search results

This study is evaluating a home and internet based “brain training programme” (cognitive rehabilitation programme) in cancer survivors who have noticed changes in their memory, concentration and thinking (cognition) following chemotherapy. This trial will recruit cancer survivors aged 18 and above who have completed a minimum of 3 cycles of chemotherapy in the last 6 – 60 months for an early cancer. There should be no evidence of cancer recurrence. Potential participants must report changes in their memory and / or concentration. All study participants will take part in a telephone session where they will be given skills to help manage their cognitive difficulties. In addition, half of the participants will receive the computer programme which is to be used for 4 x forty minute sessions per week for 15 weeks (i.e. 40 hours). Participants will be asked to complete questionnaires about their memory, mood, energy levels, quality of life and stress. They will also be asked to perform a 20 minute computer cognition exercise. The questionnaires and cognition exercise will take approximately 45 minutes to complete in total and these tests will be completed on 3 occasions during the trial (i.e. at baseline, on completion of the brain training programme and 6 months following completion of the brain training programme). The computer programme, questionnaires and cognition exercise can all be completed at home and participants will therefore require access to computer and internet facilities. This study will measure the effectiveness of the computer programme in improving self reported cognitive function and performance, mood, energy, quality of life and stress.

An assessment of the safety and efficacy O'Neil Long-Acting Naltrexone Implants for the treatment of substance dependence both during and after its treatment effects have diminished. Adverse events and substance abuse will be monitored for 12 months post implantation.

This study evaluates the effectiveness of surgery in treating residual disease in patients with metastatic gastrointestinal stromal cell tumours who are responding to treatment with imatinib mesylate. Patients will be randomly divided into two groups. One group will receive surgery to remove residual disease and continue imatinib therapy. The other group will receive continued imatinib therapy only. Participants will be monitored twice in first 6 months, then every 3 months for the first 5 years, and then every 6 months until any progression of disease. Who is it for? -Patients with metastatic GIST. -Patients who have taken 6-12 months of imatinib mesylate. -Patients with either stable disease or tumour regression since the start of imatinib mesylate.

This study looks at the effectiveness of surgically removing the primary tumour in patients with colorectal cancer where the cancer has already spread to distant sites. Who is it for? You can join this study if you have cancer of the colon or rectum (bowel) which has spread to further sites in the body. Trial participants will be randomly divided into two groups. One group will follow the standard practice of having surgery to remove the primary cancer, followed by chemotherapy and/or radiotherapy. The other group will receive treatment with chemotherapy and/or radiotherapy alone, reserving surgery until such a time as the disease causes bowel complications, and surgery must be performed to remove the primary tumour. Patients will be assessed before and after receiving treatment and thereafter at 3 monthly intervals until death. Quality of life questionnaires will be repeated at 1, 2, 3, 4,5 and 6 months. Studies suggest that only a minority of patients (approximately 20%) develop serious intestinal complications from the primary tumour, and that it may not be worthwhile subjecting all patients to major surgery at the outset. This study aims to find out optimal management by comparing the two treatments and their impact on overall survival and quality of life. The SUPER study hypothesises that patients with Stage IV colon or rectal cancers receive optimal palliative treatment through the combined use of chemotherapy and/or radiotherapy and do not need to undergo elective resection of the primary tumour. The SUPER study will compare two strategies in the treatment of non-curable, colon or rectal cancer cancer to determine whether the standard practice of initially undergoing surgery to remove the primary cancer followed by chemotherapy and/or radiotherapy offers best management, or whether chemotherapy and/or radiotherapy alone should be offered, reserving surgery until such a time as disease progression results in bowel complications, and surgery to remove the primary tumour must be performed.

This randomised controlled trial aims to determine whether a total hip replacement with a larger 36 mm diameter prosthetic femoral head significantly reduces the incidence of dislocation one year following total hip replacement, compared to total hip replacement with a standard 28 mm diameter prosthetic femoral head. The effect of the larger femoral head on both polyethylene wear and acetabular cup migration is also being assessed.

The primary purpose of this study is to develop an intervention in community pharmacy which gives community pharmacies a role in the primary prevention of cardiovascular disease within a multidisciplinary context.

Our primary hypothesis is that electroacupuncture (EA), as a supplementary therapy to stardard care, that is pain medication management (PMM), can effectively reduce the use of opioid medications (OMs) in the management of chronic musculoskeletal pain (CMP). About the problem: Seventeen (17%) to 20% of Australians suffer from chronic pain, with the majority of them having CMP. Moderate to severe CMP has been increasingly managed with OM. In Australia, in 1999, 13% of chronic pain patients were using some type of OMs. Since then, the consumption of some OMs has increased by 5 to 40 times. About the use of OMs: Although short-term benefit of OMs for CMP has been demonstrated, its long-term use is a problem. Studies have shown that chronic pain patients who are on long-term OMs, experience more severe pain, poorer quality of life, and are more likely to have adopted passive pain coping strategies. Thus, effective measures that reduce the OM use and OM related adverse effects are urgently needed. About EA and its benefit: Animal and human studies have shown that EA not only increases the release of endogenous opioids, but also help our body to use opioid medications more efficiently. Our pilot study (Zheng et al, EJP, 2008) demonstrated that real EA, when combined with PMM, reduced the OM consumption more effectively than sham EA did. The proposed research will employ an adequate sample size with an additional no-EA group to determine the benefit and safety of EA for the reduction of OM consumption by subjects with CMP.

Epstein-Barr virus (EBV) is associated with a number of human malignancies including nasopharyngeal carcinoma (NPC). 100% of undifferentiated NPC tumours are EBV- positive meaning the virus is localised to the tumour cells. We are attempting to develop immunotherapy as an alternate treatment for nasopharyngeal carcinoma (NPC) in addition to radiotherapy, chemotherapy and surgery. This immunotherapy would be in the form of adoptive transfer. This requires that a certain type of white blood cell found in the body known as “killer T-cells” or technically "cytotoxic T lymphocytes" (CTL) be isolated from the NPC patient’s own blood. These T cells are trained in the laboratory to become more efficient at recognising and destroying EBV infected tumour cells. Adoptive transfer is when the EBV-specific T cells are given back to the patient via intravenous infusions. This phase I adoptive immunotherapy trial aims to determine the safety, tolerability and efficacy of adoptive transfer of EBV specific T cells for NPC. The study will be carried out in collaboration with The University of Hong Kong, The Queensland Institute of Medical Research (QIMR) and The Princess Alexandra Hospital, Brisbane. A total of 50 eligible participants will be enrolled on the trial (35 from Hong Kong and 15 from the Princess Alexandra Hospital). Following informed consent, a 200-400ml blood sample will be collected from each participant and transported to the Q-Gen laboratory at QIMR in Brisbane where laboratory staff will begin to grow the T cells with a recombinant adenovirus. This process will take about 15 days. The recombinant adenovirus expresses small fragments from NPC-associated viral proteins this technique is used to stimulate the killer T cells in the laboratory. This adenovirus has been modified in such a way that it is non-infectious and does not cause any disease. This stimulation should result in the T cells being able to recognize EBV proteins on the NPC tumour that are there because of the EBV in the tumour. After recognising these proteins, the T cells will try to kill the tumour. After the killer T cells have been grown they will be purified and all residual adenovirus removed. They will be tested for safety, sterility and specific activity before being transported back to the treating hospital. The participants will undergo several baseline assessments, including blood tests. The killer T cells will be given back to the participant via adoptive transfer. Infusions of between 20-40 x 10^6 CTL will be given intravenously on a fortnightly basis, for up to six infusions. Participants will be monitored once a fortnight for the first 12 weeks and then once a month for four months. Monitoring will involve a series of blood tests and MRI scans. Participants will be on the trial for a total of 33 weeks.

This is the first human study of a novel swine flu vaccine that is designed to identify the optimum dose of vaccine, the optimum number of doses and whether or not an adjuvant is required to provide maximal protection against swine flu