ANZCTR search results

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12515000908437. This substudy will evaluate the activity of pamiparib in participants with acute myloid leukaemia or myelodysplastic syndrome with DNA repair pathway mutation (e.g. BRCA1/2), and/or BRCA mutational signature. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with acute myeloid leukaemia or myelodysplastic syndrome. Your cancer will need to harbour DNA repair pathway mutations (e.g. BRCA1/2), and/or BRCA mutational signature. Study details: Participants will receive pamiparib, to be taken orally at a dose of 60 mg twice daily. Pamiparib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo clinical assessments at 4 weekly intervals from first treatment until end of treatment.. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who have limited treatment options available to them. It is hoped that pamiparib will be well tolerated and will improve outcomes for future patients, however there may be no clear benefit from participation in this study.

Cannabidiol is a phytocannabinoid found naturally in the Cannabis sativa plant. Despite CBD’s long history of use, its medicinal properties have been somewhat anecdotal. There are very few pharmaceutically approved products on market, and these are limited to rare clinical indications (i.e. Epidiolex® for rare childhood epilepsy). Cannabidiol is being developed for a range of medicinal applications. These applications typically require CBD at high purity, which can be extracted and purified from Cannabis sativa, or synthetically manufactured. High purity CBD is a white to pale yellow crystalline solid that is insoluble in water. Consequently, CBD is usually administered in an oil vehicle. The limited aqueous solubility of CBD leads to poor oral bioavailability, which has been reported as between 3-8%. CBD has been selected for clinical development in a formulation containing TPM. It is believed that CBD TPM formulations may have improved bioavailability when compared to CBD alone, which would allow for lower doses administered to patients, or the targeting of therapeutic indications that would ordinarily need CBD doses that are so large as to be prohibitive. The proposed Phase I clinical study will evaluate the PK, safety and tolerability of an oral CBD soft-gel capsule. The PK profile of the capsule will be compared at two separate doses. Results from this study will support further clinical development of the CBD soft-gel product, with a focus on indications that can be treated with low-dose CBD.

We aim to identify complexities in the scale-up, spread and sustainability of convers-ABI-lity, an online conversation skills training program to provide scalable communication training to adults with acquired brain injury (ABI) and familiar communication partners such as family, partners and friends. We therefore seek to identify; 1. Who uses convers-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is convers-ABI-lity used? 3. Do users complete convers-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing convers-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing convers-ABI-lity? 6. How satisfied with convers-ABI-lity are the users? 7. What is the cost of delivering convers-ABI-lity? The direct evaluation of the implementation of convers-ABI-lity by end-users aims to ensure the intervention reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.

The feasibility pilot trial will recruit and randomly allocate approximately 48 adults with lower back pain to an exercise program with or without breathing cues. The 12 x 1-hour exercise sessions will be weekly for 12 weeks at University of South Australia East Campus. Some individual tailoring (progression/regression) for individual capacity will be undertaken and recorded by the physiotherapist. The intervention and control groups will experience the same standardised floor exercises, length of session, location and class numbers. The aim is to determine if the addition of specific cues to a 12-week exercise program alters participant tolerance and compliance, including dropout rate and satisfaction. The aim is not to establish evidence reliant on sample size, rather determining which measures demonstrate most relevance for future research.

We aim to identify complexities in the scale-up, spread and sustainability of social-ABI-lity, an online social media training course to provide scalable communication training to people with acquired brain injury (ABI). We therefore seek to identify; 1. Who uses social-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is social-ABI-lity used? 3. Do users complete social-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing social-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing social-ABI-lity? 6. How satisfied with social-ABI-lity are the users? 7. What is the cost of delivering social-ABI-lity? The direct evaluation of the implementation of social-ABI-lity by end-users aims to ensure the course reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.

Twenty percent of adults meet criteria for food addiction, with 70% reporting greater than four symptoms of food addiction. Food ‘addicted’ individuals have significantly lower diet quality, higher intakes of junk foods and higher weight status. The personality characteristic of impulsivity is a common risk factor for substance use and food addiction. There are currently no evidence-based interventions run by clinicians for food addiction. Current treatment options largely stem from online self-help groups such as Food Addicts Anonymous and Overeaters Anonymous which have 10 000+ members, demonstrating the clear need for services and evidence-based programs. Interventions targeting personality risk factors and motivational interviewing for other addictions, such as alcohol use, are effective. This project builds on an existing pilot study utilising a personality-based intervention for the targeted treatment of addictive overeating in individuals with food addiction and is a subgroup study of our parent study ‘Examining the efficacy of a personality-based intervention targeting addictive overeating in Australian adults: a randomised controlled trial’. The current study will determine if the personality-based intervention targeting addictive overeating has an effect on cardio-metabolic profiles and neural reward responses in individuals with food addiction at 3 months follow up. Cardio-metabolic will be assessed via a fasting blood test, and neural reward responses will be assessed via a brain scan through clinical fMRI imaging. Additionally, this subgroup study will determine if individuals with food addiction are different from those without food addiction, in terms of their cardio-metabolic profiles, genetic profiles and structural brain function. It is hypothesised, individuals with food addiction will have improved cardio-metabolic profiles and altered neural reward responses at 3 months post-intervention compared to baseline, and individuals with food addiction will have different cardio-metabolic and genetic profiles (assessed via a fasting blood test), and heightened neural reward responses, compared to individuals without food addiction at baseline. If successful, this project will provide an evidence-based treatment for those individuals with food addiction and addictive overeating behaviours in the community and clinical services.

The care partner of a person with Alzheimer’s disease can be as much a “client” of a health service as a patient. They are heavily involved in facilitating the treatment and engagement of a patient, and thus need to be supported in this role that may have been unexpectedly thrust upon them. Care partner burnout has been identified as one of the main reasons individuals with dementia enter long-term care, therefore early intervention to support and empower care partners is critical. Interventions for care partners of individuals with a chronic illness have been shown to improve the psychological wellbeing of care partners. However, few empirical studies have been completed on the benefits of early intervention for care partners of individuals with Alzheimer’s disease. ECLIPSE - a newly designed, weekly, small-group-based intervention - will be provided over a four-week period to care partners of individuals recently diagnosed with Alzheimer’s disease. This project aims to implement and evaluate the effectiveness of ECLIPSE to improve psychological wellbeing, and to empower and support care partners.

The aim of this study is to assess the efficacy and patient perceptions of an 8-week exercise and educational support program for women with metastatic breast cancer in improving disease-specific quality of life, symptoms of anxiety and depression, and exercise capacity, as well as reducing pain and fatigue. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have a diagnosis of metastatic breast cancer. Study details All participants will take part in an 8-week program consisting of two 60-minute exercise sessions per week involving aerobic and strength-based exercises, as well as two 60-minute educational support sessions per week. Exercise sessions will be supervised and run at the Cabrini Exercise and Wellness Centre. Once the patient is safely established on a supervised exercise regime, an unsupervised home exercise program will be prescribed for them to complete at home. Educational support sessions will cover a range of topics including mindfulness, energy conservation, superannuation and services, sleep, nutrition and lymphoedema, with the option to ‘opt out’ of particular sessions or request additional one-on-one support sessions with the social worker or psychologist if desired. Participants will be required to fill out a number of questionnaires and perform brief tests of physical function before the start of the program and after completion of the 8-week program. It is hoped that this study will demonstrate that a combined exercise and educational support program is effective for managing undesirable side effects of metastatic breast cancer and its treatment, and at improving functional exercise capacity and quality of life in these patients.

Adults who were born prematurely and mothers who give birth to a preterm baby are at increased risk of cardiovascular disease but neither are included in New Zealand’s risk assessment guidelines. As part of a wider project investigating the impact of premature birth on cardiovascular health we will invite the New Zealand Very Low Birth Weight cohort (born <1500g) and their mothers to have their cardiovascular disease risk assessed and compared to a control group. We will compare cardiovascular risk factors, cardiovascular events, general health and reproductive history in the premature-born NZ VLBW cohort and controls at age 35 years (2021). Cardiovascular events and risk factor trajectory will be compared to cardiovascular risk estimations using health data collected as part of risk factor data collected at 28 years of age using validated calculators (such as NZ PREDICT guidelines). We will also compare cardiovascular disease event rate and all-cause mortality in mothers of the NZ VLBW cohort compared to mothers of controls and calculate and compare five year cardiovascular risk estimates using the NZ PREDICT equations. This will be compared to actual cardiovascular disease events as part of a comprehensive evaluation of cardiovascular health planned in five years’ time. Evaluation for cardiovascular risk in participants will be based upon medical history, blood pressure and anthropometric measurements and blood testing for diabetes and dyslipidemia. This study and our wider research project will help to inform recommendations around cardiovascular risk screening after preterm birth/delivery.

The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001. Part B will evaluate the combination treatment of ACT001 with pembrolizumab in patients with recurrent GBM (Glioblastoma Multiforme brain cancer) only. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with glioblastoma. Those who participated in Part A of the study (ACTRN12616000228482) may be eligible to also participate in this study, subject to principal investigator approval. Study details: Participants will receive oral ACT001 twice every day for 21 days, together with intravenous (IV) infusion of pembrolizumab on the first day. After 21 days, once the safety of this treatment is determined, all participants will be given the treatment in recurrent 21-day cycles until tumour progression or adverse event. Researchers will take a number of blood samples from the initial 3 participants in Day 1 of the first and second 21-day cycle, to examine the rate that the body processes the drug. MRI scans and assessments of treatment response will be taken before treatment and then every 9 weeks to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether the combination treatment of ACT001 with pembrolizumab can be safely given to cancer patients, and provide information on the rate of processing of ACT001 by the body when pembrolizumab is also given. Using this information, researchers hope to find if the combination of ACT001 and pembrolizumab is safe and effective.