ANZCTR search results

A novel medical device, the Atmo gas-sensing capsule, has emerged as a technique capable of reliably assessing regional gastrointestinal transit time. In order to standardise assessments made using the Atmo gas-sensing capsule, the meal that is eaten as part of the investigation needs to be consistent across assessments. An alternative nutrient bar has been developed for this purpose to approximate the nutrition profile and form of a predicate nutrient bar. This study aims to compare how the two nutrient bars impact regional gastrointestinal transit time, to determine whether the newly developed, alternative nutrient bar is suitable for future evaluations of transit time using the Atmo gas-sensing capsule.

Persistent cancer-related fatigue affects many cancer survivors and can have impacts on their physical, psychological and emotional wellbeing. Cognitive Behaviour Therapy (CBT) is a recommended treatment for persistent cancer fatigue in survivors. CBT focuses on changing unhelpful ways of thinking and modifying learned patterns of unhelpful behaviour, but traditional CBT programs are often provided over a long period of time (more than 6 months). This study aims to determine if a stepped-care model of behavioural care that involves patient self-management of fatigue symptoms followed by a shorter course of CBT is feasible and acceptable to cancer patients. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed and finished treatment for any cancer type within 3 months, and you report moderate to severe fatigue based on a series of screening questions (asked prior to enrolment). Additional eligibility criteria may apply to patients with melanoma and/or blood cancers, we recommend you contact the Public queries person listed below to see if you are eligible for this study. Study details All participants who choose to enrol in this study will be given a self-management cognitive behaviour therapy (CBT) work booklet that contains activities and educational materials (Step 1). Participants will be asked to work through the booklet at their own pace over a 5 week period, and will have access to telephone and email support after the first week. Participants who do not have any change in their fatigue levels after completing this 5-week program will then be offered Step 2, which involves an additional 4 x 50 minute face-to-face/Telehealth individual or group CBT sessions with a Clinical Psychologist. It is hoped this research will determine whether it is possible and acceptable to cancer patients to deliver behavioural therapy in a stepped-care manner rather than a standard 12-week program. If this stepped-care model is acceptable to patients, it may be delivered as part of a larger trial that could help future cancer patients with their fatigue as well.

The CANCAN trial aims to provide the evidence needed to better inform healthcare professionals in the use of medicinal cannabis in people with cancer. The purpose of this study is to investigate whether medicinal cannabis – a combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) – is effective and safe for the management of chemotherapy symptoms and side effects in people receiving treatment for cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are scheduled to undergo either at least 3 cycles of chemotherapy for treatment of a solid tumour, or autologous stem cell transplantation for treatment of a haemotological cancer. Study details Participants will be randomised (i.e. allocated by chance) to receive either the medicinal cannabis treatment or a placebo. Participants in the medicinal cannabis group will receive 400mg per day of CBD and a starting dose of 2.5mg per day of THC in the form of an oral capsule for the duration of each treatment cycle, while participants in the placebo group will receive a daily glucose capsule. All participants will be monitored for symptoms of gut distress, have blood tests and their body weight taken, and answer a number of questionnaires, to determine if the medicinal cannabis treatment has an effect on chemotherapy symptoms and side effects for up to 6 months after the completion of treatment. Participants will also be monitored over this period for whether they have used supportive care or been hospitalised, for whether they have completed or ceased treatment and why, for their response to chemotherapy, and for any adverse events. It is hoped that this study may show that medicinal cannabis will minimise the intensity of chemotherapy symptoms, and thus have beneficial effects on the outcomes of chemotherapy. Specifically, we anticipate that CBD will minimise gut injury, therefore minimising local symptoms including diarrhea, malabsorption and pain, while THC will promote food intake, improve sleep quality and decrease anxiety. We expect this to have benefits on quality of life, and the ability of participants to receive their intended dose of chemotherapy without interruptions.

Cardiac involvement remains one of the biggest killers in Fabry disease. Yet our ability predict cardiac involvement before irreversible damage occurs remains limited. The chief reason for this is the differences in Fabry disease presentation that remains unexplained by biomarker or predictable natural history. Current tools, such as biomarkers (e.g., enzyme activity level, plasma Gb3, etc.) and genetic testing give a good measure of 'general' Fabry progression or diagnosis; but these are non-specific to phenotype or individual organ involvement. Further insight into which patients are at risk of developing heart complications would direct clinicians to consider commencement of Fabry-specific therapy in potentially high-risk patients. Markers and mechanistic insights that explain individual susceptibility to cardiac fibrosis and hypertrophy in the context of Fabry disease may also have broader implications to understanding heart failure and cardiomyopathy more broadly.

This study is a prospective, randomized, longitudinal study of the clinical and biomechanical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using nagivated assisted technology. We hypothosize that Inverse Kinematic alignment (iKA) will result in better Oxford Knee score (OKS) and satisfaction visual analogue scale (VAS) score compared to mechanical alignment (MA).

This study builds upon our world-first clinical trial of nicotinamide in glaucoma (ACTRN12617000809336) demonstrating the potential protective role of vitamin B3 (nicotinamide) supplements in people with glaucoma. Glaucoma causes progressive loss of nerve tissue in the eye, and irreversible vision loss. This study investigates the effect of taking nicotinamide supplements over 2 years on the eye’s structure and function compared to placebo. The primary aim of this study is to determine whether nicotinamide supplements in participants with glaucoma leads to reduced rate of progression in visual function measured using visual fields over 2 years. Participants diagnosed and treated for glaucoma will be invited to undertake the study. They will be randomly assigned to take nicotinamide or placebo daily for 24 months. Clinical tests including visual fields and imaging of the eye are performed at baseline, and every 4 months post-intervention.

Patients with persistent or chronic pain often have underlying chronic conditions that can be overlooked such as anaemia, which can have significant effect on the quality of life of patients. A recent pilot study involving patients who have persistent pain for greater than 12 months have shown that 59% have iron deficiency. This study will follow on from the pilot study to examine if intravenous iron infusions do improve this cohort of patients fatigue levels, their health-related quality of life, pain levels and reduce pain medication use. This study will be conducted at a Quaternary hospital in Brisbane as a single-site, single-blinded, parallel-group randomised controlled trial. We plan to recruit 160 participants who will be randomised to receive either intravenous iron infusion or placebo. The outcomes will be measured using specific validated surveys and questionnaires related to fatigue (FACIT), health-related quality of life (SF-36) and pain (ePPOC).

This study is a randomised open-label trial of the Moderna Omicron-containing bivalent booster candidate mRNA-1273.214 (mRNA-1273.214) vaccine. Participants who have received 2-3 prior doses of the any COVID-19 vaccine will be randomised into two arms: to receive a 3rd dose of the Moderna Bivalent Omicron vaccine on enrolment or 3 months later. Both groups will be followed-up for six months after enrolment.. We hypothesise that there will be a difference in measurable SARS-CoV-2 antibody responses in people who receive a Moderna Bivalent Omicron COVID vaccine booster immediately on enrolment in the study compared to those who wait an additional three months before receiving a booster dose. A booster dose of the Moderna Bivalent Omicron r vaccine will be administered intramuscularly. One dose (0.5 mL) contains 50 micrograms of mRNA-1273.214 (25-µg each ancestral Wuhan-Hu-1 and omicron B.1.1.529 spike SARS-CoV-2 mRNAs) (embedded in lipid nanoparticles). This is a single-site study with interested potential participants attending the Royal Melbourne Hospital for recruitment, the consenting process and study visits. A total of 64 participants will be recruited (32 per arm).

Traditionally, combination therapy has not proven to be effective in Myelodysplasia (MDS) given the increased toxicity of drugs used in combination with standard therapies. The aim of this master platform trial is to test a range of novel treatments aimed at targeting MDS to find safe and effective drug combinations. You may be eligible to participate in this study if you are aged 16 or older (depending on the study, this may be limited to 18 and older) and you have a diagnosis of either MDS or acute myeloid leukemia (AML) with less than 30% blasts. If you choose to enrol in this trial you will undergo a screening process where blood and bone marrow samples are taken prior to starting any treatments. The study doctors will assess your samples for specific MDS markers and will then prescribe a combination treatment that may be effective. Participants who do not respond to treatment or whose disease worsens may be removed from treatment and be reassessed for the next best treatment option to receive. During treatment participants will be assessed regularly which will include physical exams, blood tests, ECG (heart monitoring), bone marrow biopsies, toxicities to the treatment, quality of life. After treatment, disease will continue to be monitored and if participants have MDS progression or morphological relapse they will be assessed for the next best treatment option. It is hoped that the results of this trial will help us to determine which drug combinations are safe (minimal side effects/toxicity) and effective for treating MDS.

This study aims to evaluate the effectiveness of a new online treatment for body dysmorphic disorder (BDD) in adolescents. BDD is an underrecognised and undertreated mental health condition, characterised by a preoccupation with perceived flaws in physical appearance. There is a paucity of research exploring the disorder among youth. In adults with BDD, cognitive-behavioural therapy (CBT) has been shown to be an effective treatment. There is some evidence that CBT can be effective for some youth with BDD, however many young people remain impaired by their BDD following treatment. Therefore, this study aims to test a developmentally-tailored CBT approach to treating adolescent BDD. The therapy will be delivered via videoconference to families, to increase accessibility to the study.