ANZCTR search results

The primary purpose of this trial is to evaluate the safety, clinical outcomes, patient preferences and economic benefits of reduced margins for radiation therapy for prostate cancer, with the use of the Clarity Autoscan ultrasound system. Who is it for? You may be eligible to participate in this trial if you are aged 50 or over and have been diagnosed with prostate cancer, for which you are scheduled to commence radiation therapy treatment. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either a reduced margin around the prostate during radiation therapy of 3-5mm, or to receive the standard margin of 7-10mm. All patients, regardless of allocation will have fiducial markers inserted prior to commencement of treatment, and will have the Clarity Autoscan ultrasound monitoring prostate motion throughout treatment, increasing the accuracy of treatment. The allocated treatment protocol will continue for all radiation therapy treatment sessions (up to 39). Researchers will ask participants for their preference regarding monitoring during radiotherapy, and the acceptability of the Clarity Autoscan system. Participants will also be followed up for up to five years post treatment to assess side effects and for one year to evaluate the cost-effectiveness of the motion monitoring. It is hoped that the findings from this trial can be used to inform a health technology assessment reviewing the safety, efficacy and cost-efficacy of reduced margins during radiotherapy for prostate cancer using the Clarity Autoscan system.

This study aims to determine if Bacopa monnieri supplementation improves brain health, cognition and well-being in older adults undergoing regular cognitive training. 36 healthy adults aged 55 years or above, will be asked to complete 3 hours of cognitive training at home a week for 12 weeks, while consuming either 320mg of Bacopa monnieri extract or placebo per day. Participants are asked to attend three testing sessions at Swinburne University Hawthorn campus, which includes a screening and practice visit (approx. 2 hours) where consent is obtained, eligibility assessed and participants familiarised with study measures and procedures, and a baseline visit and final visit (3 hours each, 12 weeks apart) where study outcomes are assessed. Procedures measuring treatment efficacy include brain imaging using MRI, blood collection for bio-markers of inflammation and brain health, cognitive assessment of memory, reaction time and attention, and questionnaires assessing mood and everyday functioning.

Sulforaphane is a naturally occurring compound belonging to the isothiocyanate group. It can be obtained naturally through cruciferous vegetables with broccoli sprouts being one of the richest sources. Sulforaphane obtained through ingested broccoli sprouts are activated by myrosinase, a chemical that is released by chewing of the vegetable. Myrosinase is also present in the gut flora of individuals and mediates the conversion of precursor compound to bioavailable sulforaphane. Previous studies in humans has demonstrated the antioxidative, anti-inflammatory effects of Sulforaphane and its ability to protect against endothelial dysfunction and end organ damage. Therefore, we believe sulforaphane may have a potential clinical utility in maternity care as a ‘low risk’ intervention for the treatment of pre-eclampsia. The aim of the research project is to evaluate the pharmacokinetics (PK) of sulforaphane obtained through the ingestion of a natural broccoli sprout supplement in a cohort of healthy women 24-36 weeks pregnant with one baby, n=6 Participation involves the ingestion of two tablets (together) of the broccoli sprout supplement with associated PK blood sampling at nine pre-determined time points, one just prior to ingestion of the supplement and then following at: 15, 30, 60, 90, 120, 240, 480, 720 minute intervals.

The current method of treating patients with bleeding disorders such as haemophilia A and haemophilia B is by injection of recombinant factor VIII or IX, respectively. Even though there is evidence that prophylactic (continuous) injection of factor prevents long-term complications of the disease, cost is prohibitive. The cost for “on-demand” treatment is approximately $100,000, or more, per year for many adults. Some patients form “inhibitors” (neutralizing antibodies against coagulation factor) which increases the amount of factor needed for treatment, and the associated expense. In view of the cost, inconvenience of injections and the potential for inhibitor formation, effective alternative therapies would be welcome by hemophilic patients. One research approach for haematological diseases involves gene transfer. A research effort towards clinical gene transfer for haemophilia, including Professor John Rasko at RPAH, has focused on viral vector delivery systems based on the adeno-associated virus (AAV). Clinical trials over the past decade have demonstrated the utility of AAV vectors for the delivery of normal factor transgenes to muscle and liver. However, immune responses against AAV capsid (the viral vector “coat”) have prematurely terminated factor expression, most likely by immunologically “clearing” vector-transduced hepatocytes. Initial data indicates that approximately 50% of the haemophilia patient population has pre-existing immunity to AAV, as measured by serum antibodies. Clinical studies incorporating immune modulation have been approved, but there is a need to know the AAV immune status of a number of patients, prior to proposing the research study to patients. Therefore, this study intends to screen a number of patients with haemophilia A and B in order to determine their immune system response to AAV, and the genotype of their disease-causing mutation. Depending on the results of these tests, participants may be offered the opportunity to participate in interventional gene therapy trials for their particular disease.

Knee osteoarthritis is a major problem in Australia and there is no cure for the disease. Non-drug strategies that help people to self-manage the condition are needed. Different types of shoes influence forces acting across the knee joint. We know that increased knee forces can contribute to the knee pain associated with knee osteoarthritis, and that high forces can increase the risk of the disease worsening over time. It is recommended that clinicians provide advice on “appropriate” footwear for people with knee osteoarthritis. However, there is little evidence from clinical trials to determine which shoes are best for self-managing knee osteoarthritis. We are conducting a research study to compare two classes of readily available off-the-shelf shoes on knee osteoarthritis symptoms. To do this, we will allocate people via a random process into two different groups. Participants in each group will be provided with 2 pairs of different shoes to wear daily for 6 months. To ensure that this is a fair and unbiased evaluation, we will not disclose the differences in the shoe classes between the two groups until the end of the study. There will be an equal number of participants in each group, and participants will not be able to choose which group they are in. The findings of this study will help determine which shoes are best for people with knee osteoarthritis and will guide clinicians in providing appropriate evidence-based footwear advice for their patients. The findings of this study will be published in medical journals and be presented at conferences.

This RCT will evaluate the acceptability and efficacy of a one-session Virtual Reality Exposure Therapy intervention targeting fears of blood, injection and injury, by comparing one-session of VRET with a waiting list control group (WLC). This study will also explore individual difference factors that predict better response to VRET, the mediators of response to VRET as well as the effect of the intervention on comorbid symptoms (e.g., depression), cognitions and emotions.

This Phase I, dose escalation trial will evaluate the safety and tolerability of Magellan Biologicals’ allogeneic (obtained from a donor) adipose-derived mesenchymal stem cells (MAG200) when injected into the knees of patients with osteoarthritis of the knee. This is the first time MAG200 will be given to human subjects who are not genetically related to the donor of the stem cells. Up to 40 volunteers aged between 18-65 years, will be enrolled. A maximum of four dose levels of MAG200 will be tested with 10 subjects in each dose level cohort; 8 subjects receiving MAG200 and 2 receiving placebo. The subjects and study team will not know which treatment a subject receives. Dosing will commence at the lowest dose level of MAG200 and a Safety Review Team will review the safety data of each dose level cohort before allowing progression to the next dose level to occur.

This study is a randomised trial looking at how pressure pain threshold and temporal sensory summation change following lumbar spinal manipulative therapy, by comparing this to a sham treatment. It also aims to look at how pain sensitivity differs between people with and without lower back pain, depending on the severity of lower back pain, and based on how they respond to treatment. We will recruit 80 participants with lower back pain, who will randomly receive either a lumbar or sham manipulation. Pain sensitivity will then be measured at various areas of the body for 30 minutes. Participants will then return for 3 additional visits, where pain sensitivity will be measured again before receiving a real treatment, involve manipulation, mobilisation, and soft tissue therapy as deemed appropriate for that participant. 20 healthy volunteers without lower back pain will also have their pain sensitivity measured, but will not receive treatment.

This study will investigate the role of information provision in open-label placebo administration. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on wellbeing and randomly assigned to one of three conditions: no-treatment control, standard RCT placebo information, or enhanced open-label placebo information.

Childhood obesity is a global health problem, affecting one in five Australian children by age five. Given the persistence of obesity from childhood into adulthood, it is essential to establish healthy eating habits from a young age. Monitoring obesity trends, evaluating scaled-up obesity intervention programs and making informed policy and practice decisions depends on the availability of suitable assessment tools. However, research and evaluation in this area is limited by the lack of validated and ‘fit-for-purpose’ tools for measuring food intake of young children. Short food questionnaires have the capacity for rapid reporting of food intake, are quick to administer in a variety of formats and have low respondent burden, making them an appealing and viable approach to monitor population dietary intake and evaluate intervention programs. However, a recent review of short questions assessing child food intake found that no single set of short questions provided reliable and valid estimates of intake across a range of food groups. Better understanding of the thought processes and recall strategies used by parents when responding to questions about their children’s food intake can improve the validity and reliability of short food questions. Cognitive interviewing approaches are used to study the way people understand, mentally process and respond to questionnaires, and can therefore provide novel insights for improving short food questions. The aim of this study is to use cognitive interviewing to improve understanding of how parents of 3-7 year old children report what, how often and how much their children eat to improve the measurement accuracy and acceptability of questionnaires measuring young children’s food intake. A secondary aim is to understand why certain food groups perform worse than others in measuring children’s food intake. This study will use semi-structured cognitive interviews, combining think-aloud and retrospective probing question approaches to evaluate question comprehension and recall strategies used by parents when reporting their children’s intake of discretionary foods, cereals and grains, meat and proteins and vegetables. Interviews will be audio-recorded, transcribed verbatim, and analysed for themes related to understanding and interpretation of short food questions and recall strategies used. The findings of this study will used to improve the design of short questions measuring young children’s food intake.