ANZCTR search results

Shogaols are biologically active constituents of ginger which have a chemical structure similar to gingerols. The most common constituent is 6-Shogaol which has been shown to be a promising anti-cancer and anti-inflammatory agent that also possesses strong hepatoprotective effects (Zhang et al., 2019). In a small investigative study among six early-stage, transfusion-independent patients with MDS, Golombick et al. (2017) found that 6-Shogaol caused a decrease in the serum ferritin (SF) levels of three patients who had elevated SF at baseline. Upregulation of hepcidin levels was observed in two of these three patients, possibly through an improvement in liver function with 6-Shogaol supplementation. Hence, 6-Shogaol, a natural food derivative, may lower the iron overload by decreasing iron absorption. Such promising findings call for a more extensive study to confirm the potential beneficial effect of 6-Shogaol in low-risk MDS patients with SF levels greater than or equal to 100ug/L due to ineffective erythropoiesis. Furthermore, whether the lowering of SF levels in this group of patients can translate into improvements in cytopenias and QoL also requires investigating.

This multicentre, randomised trial aims to determine whether a single preoperative dose of intrathecal morphine with local anaesthetic in patients undergoing elective minimally invasive major abdominal surgery improves quality of recovery as measured by the QoR-15 score on post operative day 1 where a difference of 6 is deemed clinically important. Patients will be randomised into the intervention group (preoperative injection of intrathecal morphine 200 mcg with local anaesthetic + multimodal analgesia) or the control group (multimodal analgesia). A dose increase of intrathecal morphine to 300mcg will occur after recruiting the first 100 patients and following review of safety data. Secondary outcomes of interest include cumulative opioid consumption over the first 3 postoperative days, dynamic and rest pain scores, return of bowel function, opioid related adverse events, hospital length of stay, persistent opioid use and pain at day 90.

This study aims to determine if we can train maternity staff in Healthy Conversation Skills to support them to provide pregnancy weight gain care to pregnant women. We hypothesise that after receiving the Healthy Conversation Skills intervention, antenatal care providers will have higher competence and confidence, and report less barriers, to having behaviour change conversations about weight gain with pregnant women. This study will be conducted as a single-arm, pre-post study with staggered implementation of the 2-month Healthy Conversation Skills intervention in three health sectors within the Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidenced-based strategies including leadership support, service champions, community of practice meetings, clinician training, educational materials and prompts and reminders. Study outcomes include changes in antenatal care provider’s competence, confidence and barriers to having behaviour change conversations with patients, and adoption of Healthy Conversation Skills. Implementation processes of fidelity, reach, acceptability and appropriateness of the intervention will also be measured. A cost analysis will be undertaken to assess the cost of the Healthy Conversation Skills intervention.

Older adults who receive aged care services within their own home commonly experience depression. Physical health is often prioritised in this population and mental health concerns can remain overlooked and undertreated. A new mental health model of care, Enhanced Management of home-Based Elders with Depression (EMBED) has been developed to meet the growing need for accessible and tailored psychological care for home aged care recipients. This study aims to evaluate the effectiveness of the EMBED intervention, as well as the costs and benefits of this approach.

This randomised controlled trial of 120 pregnant people aims to evaluate the efficacy of a gut health-focused, smartphone-delivered, prenatal dietary program (Bugs & Bumps), compared to a smartphone-delivered program focused on the Australian Dietary Guidelines, for: (1) improving diet quality during pregnancy, (2) altering microbial or inflammatory biological pathways that may underpin neurodevelopment, and (3) influencing mental health-related outcomes in children.

Steroid-Reducing Options for ReLapsING PMR (STERLING-PMR): a pragmatic, randomised trial to compare the clinical and cost-effectiveness of adding immunomodulation to steroid-tapering treatment for patients with relapsing PMR, versus steroid-tapering alone. This is a Multi-centre, Phase III, parallel-group, open-label, randomised controlled trial with internal pilot. Internal Pilot: A 12-month internal feasibility phase will determine the likelihood of achieving i) opening of centres, ii) planned recruitment rate, and iii) achieving the recruitment target of 200 participants (41). An internal review will also be conducted after 8 months, corresponding to one-third of the total recruitment phase (42). At the end of the internal pilot phase, if Amend (amber) criteria are met, then a recovery plan detailing remedial actions will be submitted to the funder. If this is approved, the trial will proceed with caution This study aims to determine the clinical and cost-effectiveness of adding a disease-modifying anti-rheumatic drugs (DMARDs) to prednisolone-tapering treatment in relapsed PMR patients. The primary objective to test whether adding a DMARD to usual-care prednisolone reduces patient-reported cumulative steroid dose requirements over 18 months, compared with usual-care alone; within a pragmatic RCT design. The secondary objectives will be assessment of PMR symptom severity and disease activity; time to stopping steroids and to steroid-free remission; cumulative steroid dose; AE; quality of life; work participation; diagnosis of adrenal insufficiency or GCA; and the impact of increased referrals on Rheumatology service capacity.

The primary aim of this study is to test the effectiveness of an online Cognitive Behavioural Therapy (iCBT) intervention (called CarersCanADAPT) for carers of people with cancer in reducing symptoms of anxiety and depression compared to carers in the wait list control condition. Who is it for? You may be eligible for this study if you are an adult who is a primary carer for an adult diagnosed with cancer. Study details Participants will be asked to complete the CarersCanADAPT 6 week online cognitive behavioural therapy program. You will be randomly allocated to join either the immediate access group or the waitlist group. Either way you will receive access to the CarersCanADAPT program, however those people in the waitlist group will get access to the program in 14 weeks’ time. You will also be asked to complete an online initial (baseline) questionnaire, and 2 more questionnaires at 6 and 14 weeks after beginning the trial. If you are allocated to the waitlist group, you will also be asked to complete an additional 2 questionnaires at 20 and 28 weeks after beginning the trial. This research offers an opportunity to test the effectiveness and implementation of an evidence-based online support module for carers, which if found to be effective can be broadly disseminated and potentially implemented into routine care.

Missing a diagnosis of primary aldosteronism (PA) leads to adverse patient outcomes above and beyond hypertension. A simple blood test is available to screen for this common and potentially curable condition, but is severely under-utilised. Interventions including education and clinical decision support are likely to increase PA screening in primary care where the vast majority of hypertensive patients are managed. A well-powered trial that incorporates strong implementation strategies and health economic analyses is what we are proposing to address the issue.

The purpose of this trial is to assess efficacy of an induction phase of combination therapy with asciminib plus low dose dasatinib in newly diagnosed chronic phase CML (CP-CML) with high-risk genetics, with respect to achievement of major and deep molecular response. CML14 (ASCENDANCE) is a successor trial to the ALLG-sponsored CML13 (ASCEND-CML, ACTRN12620000851965). CML14 aims to further improve outcomes through the use of our NGS panel to identify AGAs, and offer these patients with AGAs frontline treatment with combination asciminib / dasatinib therapy. Who is it for? You may be eligible for this study if you are aged 18 and above and have been newly diagnosed with CP-CML. Study details Participants who choose to participate in this trial will receive treatment with asciminib monotherapy at 80mg daily for the first 4 weeks. At the end of this period, New Generation Sequencing (NGS) and cytogenetic results will be available from the central and local labs. The presence of additional genomic abnormalities (AGA) will be defined by the central lab for each case as per predefined criteria. Patients with evidence of AGAs and high risk ACAs will be assigned to the high risk cohort, and will receive combination treatment of asciminib 80mg plus dasatinib 50mg daily - All patients with high risk will receive combination therapy between months 2 to 12. - Patients who achieved Molecular Response 4 (MR4), and confirmed at a timepoint 3 months afterwards, will de-escalate to asciminib monotherapy. - Patients without MR4 at month 12 will de-escalate to asciminib monotherapy. An extension of combination therapy to the 18th month timepoint is permitted at the discretion of the investigator - Patients with intolerance to combination therapy, despite maximal supportive therapy for the same, will deescalate to asciminib monotherapy at any time All other patients (without evidence of AGAs and high risk ACAs) will be assigned to the standard risk cohort and will continue to receive asciminib 80mg daily monotherapy. - AGA negative patients will then have to achieve predetermined targets: BCR::ABL1 of less than or equal to 10 percent, at 3 & 6 months, and less than or equal to 1percent, at 12 and 18 months to continue with asciminib 80mg daily. - Patients failing to achieve these responses will have dasatinib 50mg daily added to asciminib 80mg daily. - Patients with “warning” under ELN2020 will be offered, at investigator discretion, asciminib dose escalation to 80mg twice a day. Overall treatment duration is 2 years post-enrolment. All treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. It is hoped this research will improve overall survival and molecular response achievement and minimise treatment related morbidity and mortality for CP-CML patients.

The aim of the CUBIC Clinical Trial is to find better treatment options for Chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder that results in slowly progressive weakness and loss of feeling in the legs and arms. CIDP is commonly treated with immunoglobulin, which must be given every 3-4 weeks and patients may need to continue treatment for the rest of their lives. The purpose of this study is to see if we can use other medication to manage the symptoms of CIDP and reduce the amount of immunoglobulin needed. This could mean that CIDP patients could be treated with a lower dose of immunoglobulin or could potentially no longer need immunoglobulin. The results of this study will help to inform the medical community of the best treatment to give to people who have CIDP in the future.