ANZCTR search results

The purpose of this study is to evaluate the efficacy and safety of LDE225 as a treatment for patients with metastatic sarcoma who can not be treated by surgery. Who is it for? You may be eligible for this study if you are aged 18 years or above, have a histologically confirmed diagnosis of metastatic or unresectable sarcoma with no known curative treatment options, and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial details: In this study, you will receive the drug LDE225 in the form of 4x200mg capsules daily, taken orally until your disease progresses. You will be required to attend regular clinic visits for routine tests and assessments.

Corticosteroid and local anaesthetic injections (often called cortisone) are commonly used to treat shoulder pain. For over 10 years in the UK, physiotherapists with additional training in medicines and injecting, have been able to independently give these injections. UK services involving physiotherapist injecting have been found to be effective and help patients get appropriate care sooner. In Australia physiotherapists are not normally permitted to prescribe or inject. We want to see whether allowing an appropriately trained physiotherapist to give shoulder injections, would be feasible or beneficial for Gold Coast patients. We will use an experienced Australian physiotherapist who has completed the necessary prescribing and injecting training in the UK, has 5 years experience of giving these injections to patients in the UK and has undertaken a further period of supervised injection practice in Australia. Our research will compare this physiotherapist with a Specialist Orthopaedic Surgeon in relation to decisions about who should be offered an injection and responses to the injection.

The focus of this study was to investigate the effect of the combination of chronic high intensity interval exercise, a Mediterranean diet, and regular fish oil ingestion on improvements in body composition (body fat) and metabolic syndrome markers in overweight women.

Intensive care acquired weakness is a common problem following an ICU admission and leads to significant impairment in physical function and strength which is most prevalent in individuals affected with sepsis. Muscle mass reductions occur rapidly with up to 20% lost within the first week alone, this is accelerated in sepsis with greater muscle protein degradation. Whilst early rehabilitation commonly involving mobilisation has been shown to be both feasible and safe, it often is delayed in commencement as it relies on the individual being alert and able to participate in therapy. This trial involves the use of an intervention which can commence early in the ICU admission to try to minimise the muscle changes that occur without the direct need for patient participation and engagement. This trial will examine the effectiveness of functional electrical stimulation assisted cycling using a supine cycling machine and cycling alone compared to standard care in individuals with sepsis within the intensive care unit. Within a subgroup of 20 individuals biomarker analyses will be performed to try to understand the cellular and molecular mechanisms responsible for the changes observed.

This pilot study aims to define the variation in endpoint measures in men who are prescribed radiation therapy (RT) with or without androgen deprivation therapy (ADT). This will allow the determination of a sample size sufficiently powered to detect such a difference so that a formal randomised controlled trial might be designed. Who is it for? This study is open to men aged 40-90 years with early stage prostate cancer, without any neurological conditions and absent from any other bladder conditions or secondary malignancies. You will not be eligible to participate if you have had any type of abdominal surgery in the past 2 years. You may also be allowed entry to this study if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy, or NOT receiving (ADT) prior to beginning scheduled radiation therapy. Trial details: In this study, you will be randomised to one of two treatment arms. For Arm 1, if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy (ADT) or NOT receiving ADT prior to beginning scheduled radiation therapy, you will receive a specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction. This intervention will be tailored to you and delivered one on one by a physiotherapist. All men in Arm 1 of the study will receive a copy of a pelvic floor exercise DVD which they will be encouraged to use. If you are receiving radiation therapy alone WITHOUT androgen deprivation therapy, you will meet with a physiotherapist for review immediately after your radiation therapy, and then at 1 and 3 months after it. If you ARE receiving ADT, you will need to exercise for 6 months prior to your scheduled radiotherapy, and these exercises will be tailored to you. For Arm 2, you will receive the current, usual care with no additional instructions when you undergo your radiation therapy, except in relation to having empty bladder and bowels at each radiation therapy session. All men in the study who are receiving Androgen Deprivation Therapy will be given the option to take part in “The Man Plan", an individually tailored general exercise and fitness regimen, which includes support, education and exercise options but with no attention paid to continence promotion or pelvic floor muscle function. The program will be supervised by local exercise physiologists and delivered in a format that suits you best.

We will conduct a program of work that includes a randomised controlled trial (RCT) of the psychoeducation counselling intervention (Phase 1), an economic evaluation (Phase 2) and a qualitative investigation (Phase 3). Phase 1 will determine the efficacy of a mid-wife-led psycho-education counseling intervention to address women's childbirth fear and enhance confidence. The intervention aims to assist women to identify and work through distressing and/or fearful elements of childbirth, review their expectations and/or previous birth experiences, and understand their birth choices. Phase 2 intends to assess the cost effectiveness of the intervention relative to maternal and neonatal outcomes. Phase 3 aims to identify any differences in the narratives of women's antenatal experiences in the control and intervention group. A random sample of women will be interviewed to explore their childbirth fears and anxieties and how these influences decisions about mode of birth. Participants will also be asked to evaluate their experience of the intervention. Design: We will conduct a randomized controlled trial (RCT) of a psychoeducation intervention (Phase1) , an economic evaluation (Phase 2) and a qualitative investigation (Phase 3). Hypotheses: Relative to women allocated to the control group, women receiving the intervention will (1) report lower levels of childbirth fear, anxiety and depression at term; (2) have high confidence and self efficacy in their ability to give birth ; and (3) demonstrate superior outcomes on mental health indices and adjustment to motherhood in the postpartum period. Outcome Measures: The primary outcome measure will be a reduction in childbirth fear. Secondary outcomes include improved confidence to give birth, childbirth self-efficacy, social support, decisional conflict, obstetric and mental health outcomes, maternal and neonatal outcomes, quality of life and use of health services. Setting: Antenatal clinics of Gold Coast, Logan and Redland Hospitals. Sample and Sample Size: Pregnant women in their 2nd trimester (12-22 weeks) will be invited to participate. A sample size of 150 participants in each group is required (recruitment approx n=1200 women for assessment of birth fear prior to randomization). Around 40 women (20 from each group) will be randomly selected and invited to participate in an in-depth interview about their experiences (Phase 3). Inclusion Criteria: All women attending the antenatal clinics of participating sites in the second trimester of pregnancy will be invited to participate. They must be able to communicate sufficiently to discuss their concerns about birth and be 16 years or older. Those participants reporting high fear of childbirth on the W-DEQ will be randomised. Exclusion Criteria: If after recruitment women come to expect a perinatal death (e.g. congenital abnormality incompatible) or stillbirth they will be given an opportunity to withdraw from the study. If they opt to continue they will be offered counselling support and receive newsletters if they request. Follow up questionnaires containing parenting questions will not be administered.

This research will explore the effect of arm dominance on vein diameter and whether vein occupation ratio is predictive of DVT. This will inform current practice and assist in the development of an evidence based protocol for vein assessment and choice to enhance patient safety.

The study will be assessing whether rectal side effects from radiation treatment can be reduced, by using a spacing agent between the rectum and prostate gland. The agent is a gel, which is injected in the space between the prostate gland and rectum, in order to increase separation between these two structures. The idea is that the rectal radiation dose and hence side effects, will be reduced by the increased separation.

Ablation techniques are used to directly destroy tumours within an organ. The location of the tumours is predetermined with imaging. With image guidance, needles are inserted through the skin (percutaneously) into the tumour and an energy field (heat, cold, microwaves, ultrasound etc) is used to destroy the tumour cells. Irreversible Electroporation (IRE) is a new ablation technology that has been shown to have advantages over other more established technologies. It uses high voltage direct electrical current to open the cell membranes and destroy tumours but spares surrounding tissues and vital structures such as nerves and blood vessels. The Study: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, mainly incontinence and erectile dysfunction, that diminish the quality of life of prostate cancer sufferers and impact on patients’ decision to undergo early, potentially curative treatments. These side effects are due to procedure related damage of the blood vessels, ureter and/or neurovascular bundle. New treatments that limit damage to these structures have the potential to improve patient outcomes. Ablation with Irreversible Electroporation (IRE) has been shown to be effective in destroying tumour cells and to have the advantage of sparing surrounding tissue and vital structures such as blood vessels and neurones. It is therefore postulated that this advantage may help reduce or avoid these side effects. The purpose of this study is to evaluate the safety, precision and cost of minimally invasive, percutaneous, image guided IRE for the ablation of prostate cancer. Who is it for? This study is eligible for up to six patients diagnosed with confirmed prostate cancer with no evidence of lymph node or distant metastases, categorised as low risk (as defined by the American Urological Association Guideline for Management of Clinically Localized Prostate Cancer: 2007 Update, as a clinical score of T1-2a, a Gleason score of 7 (3+4 only) or less, and a PSA less than or equal to 10 ng/ml) and scheduled for a radical prostatectomy by the treating urologist will have the IRE procedure 14-30 days before the prostatectomy. Participants will have preprocedure urological and prostate cancer assessments (Expanded Prostate Cancer Index Composite (EPIC) and International Prostate Symptom Score (IPSS). A specified ablation zone will be predetermined using the same preplanning used for conventional brachytherapy treatment. The procedure for planning and performing brachytherapy is well established in the Radiation Oncology Department at The Alfred. It involves determining the volume (size and shape) of the prostate. Trial Details In this study, you will undergo Irreversible Electroporation (IRE) procedure which involves two fine needle electrodes being placed percutaneously into the prostate in the same way as a biopsy is performed. An electric current is passed between the needle electrodes, which causes the pores of the cell membranes to open, thereby killing the cells. The procedure will take about an hour and a half, and will be performed by either the study urologist or study radiation oncologist with assistance with the technology by the study radiologists. You will then be followed up at 1, 2 and 4 weeks, where testing for any adverse events and urological and prostate assessments will be performed. When the prostate is removed it will be examined histologically (microscopically) to ascertain the effectiveness of ablation by the Anatomical Pathology Department at The Alfred. We will be able to know if complete ablation of the specified area was achieved.

This study will evaluate the effect of combining standard chemotherapy with the drug, BNC105P, for the treatment of partially platinum sensitive ovarian cancer. Who is it for? You may be eligible to join this study if you are a female aged 18years or above and have a diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, for which you have undergone first or second line platinum based chemotherapy. Your cancer should not have progressed for at least 4 months following this chemotherapy. Trial details There are two parts to this study. Each participant will be involved in one part only. In part 1 of the study, participants will undergo chemotherapy with carboplatin, gemcitabine, and BNC105P for up to 6 cycles (each cycle is 21 days). Subsequent patients will receive escalating doses of these drugs in order to determine the maximum tolerated dose. Participants will then undergo a further 6 cycles of maintenance therapy with BNC105P only. Participants enrolled in part 2 of this study will be randomly (by chance) allocated to one of two groups. Both groups will undergo standard chemotherapy with Carboplatin and Gemcitabine for 6 cycles (each cycle is 21 days). However, one group will also receive the maximum tolerated dose (determined in part 1 of the study) of BNC105P during these cycles. Both groups will then undergo a maximum of 6 cycles of maintenance therapy with BNC105P. Participants in both parts of the study will be assessed at regular intervals in order to evaluate the safety of treatment, response rate, and quality of life.