ANZCTR search results

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.

General Practitioners (GP) have a key role to play in the care of dying patients. General practice is defined by the continuity of care and trusting long-term doctor-patient relationships. This means that general practitioners are well placed to provide quality end of life care to patients. This research explores the feasibility and acceptability of a general practice based case-finding approach to care planning of patients nearing the end of life. General practices will be recruited to test the accuracy of GPs clinical acumen in predicting which of their patients will die in the next 6 months. A number of practices will make use of a clinical prediction tool in addition to the GPs clinical acumen to see whether this improves the accuracy of prognostication. The findings of the project will help to determine the best way of identifying patients who are in need of end of life care planning. Our aim is to use the data gathered from this study as a springboard into developing a solid evidence-based intervention that could be used in general practice to identify and plan the care of patients who are nearing the end of life.

This study will look at the effectiveness of the 13-valent pneumococcal conjugate vaccine (Prevenar 13 registered trademark) in children currently or recently receiving cancer treatment. Prevenar13 (registered trademark) has been part of the regular immunisation schedule for all children at 2, 4, and 6 months in Australia since 2011. Pneumococcal conjugate vaccines are known to be very effective in healthy children under 2 years in preventing severe bacterial infections caused by Streptococcus pneumoniae, such as meningitis, bloodstream infections, chest and ear infections. Currently the vaccine is only licensed in Australia for children under 5 years and adults over 50 years of age. It is expected that it will be licensed for older children soon. It is recommended by experts that older children up to the age of 18 years with a medical condition that lowers the body’s immune system be given a dose of the Prevenar 13 (registered trademark) vaccine. Who is it for? All children aged between 1 and 18 years with a diagnosis of cancer who are either receiving chemotherapy and/or radiotherapy, or have recently completed chemotherapy or radiotherapy within the last 12 months. Patients who have completed treatment and already given a booster dose of Prevenar 13 (registered trademark) are not eligible. Trial details You will be asked to sign a consent form permitting your child to take part in the study. You will be asked questions regarding your child’s diagnosis, treatment (current or past), previous immunisations received and any side effects experienced. We will ask for your permission to access the Australian Childhood Immunisation Registry (ACIR) database for details of the immunisations. We ask you to remain for at least 15 minutes after the vaccination for observation of your child to monitor for any side effects. This is routine practice for all immunisations. You will be given a 7 day symptom diary to record any side effects, including measuring the body temperature at least once in the evening, and any other time that the child feels warm or unwell. You will be asked to bring the diary back at the next appointment. We will take a blood sample (5 mL or 1 teaspoon) to measure the immune level against the bacteria and a nasal swab to see if the bacteria is carried in the nose. The blood sample may be taken at the same time when other treatment bloods are being taken (e.g. from the “port” or Broviac). We will give the Prevenar 13 (registered trademark) vaccine by an injection in the leg or the upper arm. When you return for your appointment one month later, we will take another blood sample (5 mL) and a nasal swab to compare. If your child is enrolling and being vaccinated whilst still on cancer treatment, another blood sample (5 mL) and a nasal swab will be taken 6 months after your child has completed treatment.

We have clinically investigated GlycOmega Plus in two previous clinical trials (with no placebo arm) in participants with knee OA. Both trials demonstrated significant improvement in knee pain, stiffness and physical function at a dose of 3000mg per day for 8-12 weeks. This current trial aims to determine the clinical effectiveness of GlycOmega Plus in treating OA knee pain, stiffness and physical function at a dose of 1500mg for 12 weeks in a randomised placebo controlled design. Further we aim to assess faecal bacterial profiles to determine if participants with OA demonstrate altered bacterial growth and whether influencing bacterial growth with the supplementaion of GlycOmega Plus can be correlated to improve knee OA symptoms.

The commonest cause of death in individuals with impaired renal function is cardiovascular disease (CVD) and in 2008 contributed to 2.3% of all deaths in Australia. According to current Australian Government predictions the incidence rate of treated end stage renal disease is projected to increase by nearly 80%—from 11 per 100,000 population in 2009 to 19 per 100,000 population in 2020. This is important as data from the Australian and New Zealand Dialysis and Transplant (ANZDATA) Registry report indicates that 40% of all deaths in patients receiving dialysis were due to CVD. This is replicated in findings from the United States Renal Data System (USRDS) where CVD mortality was 42.2%. Given this, it is now well recognised that the presence of CKD is a potent risk factor for CVD. Indeed individuals with CKD have a 10-fold to 20-fold greater risk of CVD than age- and sex-matched, healthy controls. Once on dialysis CKD patients are less likely to receive cardiovascular interventions and far more likely to die than in those without CKD. CVD risk in this population is partially attributable to an increased presence and severity of conventional CVD risk factors such as hypertension, diabetes mellitus, dyslipidaemia and smoking. Additionally however there are other risk factors specific to CKD such as anaemia, abnormal calcium and phosphate metabolism and chronic inflammation. Previous work carried out by our Group in this area was funded by an NHMRC Centre of Clinical Research Excellence Award (455832). The findings of this work have provided insights into the alterations in cardiovascular structure and function undergone in CKD and the pathophysiological factors underlying CVD risk. Despite the aggressive nurse-led risk factor intervention undertaken in the original study(LANDMARK1) there was little effect on cardiovascular structure, ventricular function or outcome after 2 years of follow-up. We have ascertained, through The Australia and New Zealand Dialysis and Transplant Registry, (ANZdata), that at least two thirds of the patients in this previous trial are now deceased and of those still living, a majority have proceeded to kidney transplant. We would access the ANZdata database for dates and cause of death of the deceased patients and renal transplant status. We would access the Nephrology database at the Princess Alexandra Hospital to ascertain MACE. We will analyse the baseline data for these patients to ascertain the main cardiovascular factors that predicted outcome.