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Survival from breast cancer has improved significantly over the past 30 years. This has been due to the coordinated approach of surgery, chemotherapy and/or radiation therapy with each member of your treating specialist team contributing to your treatment recommendation. For each of these three disciplines of treatment, the conduct of clinical research has led to more effective ways of performing surgery and delivery of the best drug combinations and radiation therapy. In addition, research has also aimed to reduce side effects and therefore make each of these treatment approaches, safer and less intrusive to the quality of your life. However, it is still likely that patients will experience side effects of some kind as a result of their surgery, chemotherapy and/or radiation therapy. Currently, it is not known how often the specialist treating team or the patient’s general practitioner is managing these side effects; and how successful the treatment recommended is. Understanding the frequency of side effects that lead to an unplanned visit with a member of your specialist treating team or GP and how these side effects are managed, will allow us to plan more effective ways of coordinating the care, to ultimately improve the well-being of breast cancer patients as they undergo the various stages of their breast cancer treatment.

Submitted on 29 Jan, 2013, [Dr. Deborah Zion, the Chair of the Victoria University Human Research Ethics Committee informed this ANZCTR is required before final approval is given.] (Office for Research, Victoria University, PO Box 14428, Melbourne, VIC, 8001 or phone (03) 9919 4781.)

The purpose of this study is to find a new way of treating central sleep apnoea and drug tolerance caused by opioid medication prescribed for chronic pain. The medication tested in this study is Minocycline, a commonly used antibiotic with effects on the central nervous system's immune system. Hypothesis Minocycline will reduce the severity of central sleep apnoea in patients prescribed opioids for chronic pain. Minocycline will increase the analgesic efficacy of opioids prescribed to chronic pain patients.

There is evidence that exercise capacity is reduced in patients with type 2 diabetes. Beta-alanine has been shown to increase exercise capacity in younger, apparently healthy individuals and in elderly subjects. To date, no previous exercise trials have evaluated the effects of B-alanine supplementation on exercise capacity in a cohort of patients with T2DM. An improvement in exercise capacity in this population is valuable in that it may translate to an improvement in GLUT4 translocation and, consequently, an increase in glucose uptake. Further increases in exercise capacity secondary to B-alanine supplementation may yield significant improvements in insulin sensitivity, resulting in an overall improvement blood glucose management (HbA1c) and possibly a reduction in diabetes medications or dosages.

A 16 week intervention using encapsulated Caralluma fimbriata extract and Morosil extract in combination with lifestyle intervention to investigate whether or not Caralluma fimbriata extract and Morosil extract decrease the risk factors of metabolic sydrome

This research project is a Phase I pilot study which aims to develop and manualise a version of Mindfulness-Based Stress Reduction (MBSR) suitable for individual administration to Head and Neck Cancer (HNC) patients during the active stage of cancer treatment of curative intent. Members of our research team have previously demonstrated that HNC patients receiving treatment of curative intent reach a threshold of clinically significant distress both immediately prior to and during treatment, and also experience a decline in health-related quality of life (HRQoL) in the weeks following treatment. These findings are consistent with previous research which has shown that patients experience high levels of distress following the chronic functional impairment and disfigurement that is a common outcome of treatment for HNCs, and points to the need for effective psychological interventions to assist coping during and following treatment for HNCs. MBSR, as demonstrated by another of our team members, has shown success in reducing psychological distress associated with other forms of cancer, including breast and prostate cancer. As no reported studies exist that use MBSR with HNC patients, we intend to evaluate whether MBSR may be suitable for use in this population. We also aim to establish whether participants’ levels of psychological distress, HRQoL, mindfulness attention and awareness, intrusive cognitions, self-compassion and shame can be effectively measured in this setting. We plan to examine the feasibility (assessed through the feasibility of and compliance and fidelity to the intervention) and acceptability of MBSR therapy to participants through examining the accrual and attrition rates for this pilot study, and further explore participant’s experiences, both positive and negative, of MBSR through a post-intervention semi-structured interview. Finally, we aim to see whether MBSR delivered by a suitably qualified and experienced mental health professional is applicable and feasible for use in a hospital context.

This study looks at the effectiveness of a psychological therapy designed to support parents and carers of children and young people with cancer to make a positive transition to life after treatment completion. Who is it for? You can join this study if you are the parent of a young cancer survivor aged under 18 years who has finished treatment for either a primary or secondary cancer. Trial details: Participants will be divided into three groups. One group will take part in 'Cascade', a cognitive-behavioural program designed to help people build skills to return to normality after cancer treatment. This will take place in four 90-minute group sessions, delivered weekly over the internet. The second group will take part in an open discussion forum with the same schedule. The third group will be allocated to a waitlist before participating in one of the interventions. The study aims to monitor the distress, psychological adjustment and coping after cancer treatment. Participants complete several questionnaires and will be followed up for 6 months after participating in the online groups.

This research project is aimed at people who have had major upper gastrointestinal abdominal surgery more than three months ago, are not currently on chemoradiotherapy and who may therefore have symptoms or signs of pancreatic exocrine insufficiency (PEI). Pancreatic exocrine insufficiency (PEI) occurs when something prevents the pancreas from functioning properly. In the healthy state the pancreas releases substances into the intestinal system to break down the food we eat. In patients with major upper gastrointestinal abdominal surgery this process can be impaired due to changes in the mechanical passage of food, physiological changes from the surgery due to hormonal changes or due to poor function of the pancreas. This means that some patients with major upper gastrointestinal abdominal surgery cannot breakdown fats and so they cannot absorb fats from their food. This results in: - weight loss - or inability to gain weight - non-absorption of essential vitamins found in fats (for example vitamin A, D, E and K) - unpleasant fatty diarrhoea which is frequent, foul smelling and difficult to flush Pancreatic enzyme replacement therapy (or PERT) refers to a medication which replaces the most important of the body’s natural pancreatic enzymes and therefore can allow better breakdown and absorption of fats. This may help patients who have had major upper gastrointestinal abdominal surgery to maintain a healthy weight, and have reduction in the unpleasant side effects of frequent diarrhoea. Hence the treatment may reduce weight loss, and malnutrition, and may improve quality of life. Creon (Trademark) is the trade name of this medication, and is approved in Australia to treat the symptoms discussed already (such as diarrhoea) in patients with evidence of pancreatic exocrine insufficiency. However, it is not always prescribed by specialists and the exact indications for its use have not been fully defined. Therefore, this medication needs to be tested to establish if it is an effective treatment for some of these major upper gastrointestinal abdominal surgery symptoms.

Preeclampsia is pregnancy specific and complicates 5-8%. It is the leading cause of maternal and fetal morbidity and mortality. It is thought to occur as a result of abnormal attachment of the placenta to the uterine wall. This leads to a lack of oxygen and nutrient supply to the placenta. The ‘stressed’ and oxygen starved placenta releases ‘toxins’ that spread throughout the mother’s bloodsteam. They cause widespread injury of the mother’s blood vessels which then cause further damage to major organs: liver, kidneys and haematological impairment, nerves and the brain (causing seizures). Despite considerable research the only treatment available is termination of the pregnancy or delivery. In women that develop the disease early in pregnancy this exposes the fetus to considerable risk of the serious complications of preterm delivery. Pravastatin is a drug commonly taken by non-pregnant adults to lower the cholesterol in the blood. Importantly however, more recent research has found these drugs have also been shown to protect blood vessels. Therefore, it is possible they could mitigate the damage caused by the ‘toxins’ coming out of the placenta that injure the maternal blood vessels. If so, it could be potentially used as a treatment for severe preeclampsia. Just possibly, giving this drug to women with preterm preeclampsia might sufficiently quench the injury to the mother’s internal organs, allowing the pregnancy to safely continue to a gestation where the fetus is much less premature. Impressively, pravastatin has been tested in many animal models of preeclampsia and found to improve the disease. Importantly pravastatin didn’t cause harm in these animal models or when taken inadvertently in human case studies to either the mother or the fetus/neonate. We therefore propose a proof of concept early phase unblinded single arm study on the effect of pravastatin on the clinical course of early onset severe preeclampsia in humans. We will recruit 12 women and treat them with 40mg daily pravastatin. Inclusion criteria will be gestation 23+0 to 27+6 weeks, singleton pregnancy, with diagnosis of preeclampsia (increased blood pressure and high levels of protein in the urine).

There are 3 components to this research study.Prior to assessment patients will be asked to completequality of life (QOL) and disability surveys and a visual analogue score (VAS) of their pain. 1. The McKenzie diagnostic classification (MKD) is used during examination of patients with chronic low back pain (CLBP) to determine if a joint or disc is likely to be the source of symptoms. It requires the patient to repeat movements in a number of directions. To determine the validity of this classification system physiotherapists will assess patients attending the Townsville Hospital Pain Clinic using the MKD. A neurosurgeon will also examine the patients and at the discretion of the neurosurgeon an injection of the joint or area surrounding the spinal nerves with anaesthetic and corticosteroid will be performed. The patient will be reassessed using MKD to determine if the injection has altered the pain response and range of motion. Outcome measures will be range of motion (ROM), response to MKD and (VAS) for pain. 2. It is known that the core trunk muscles supporting the spine 'switch-off' when pain is present but it is unknown what direct effect pain relieving injections have on the short term and long term function of the core muscles. Hence, patient core muscle function will also be assessed prior to and after injection using ultrasonography. We hypothesise that the physiotherapy classification pathway will be a valid physiotherapy diagnostic indicator for CLBP patients. We also hypothesise that the deep spinal postural muscles (transversus abdominis and Lumbar Multifidus) do not immediately start to function normally post spinal anaesthetic injection.