ANZCTR search results

The primary objective of this pilot randomised controlled trial is to assess the feasibility and acceptability of a new, 5-week, group-based online-delivered stress management program for Australian with breast and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult diagnosed with breast or colorectal cancer (Stage I, II, or III) and are currently undergoing cancer treatment (e.g., surgery, chemotherapy, radiotherapy, hormone therapy). Study details Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. They will also have access to a study website, which will contain summaries of the sessions and guidance on relaxation techniques. Participants in the control group will receive information on support networks they can access, and following completion of the study period, will receive access to the study website. It is hoped that the findings from this study will help researchers evaluate the feasibility and acceptability of an online stress management program for cancer patients and guide the design of future larger trials.

Diabetes-related foot ulceration is a debilitating condition that arises in part due to high mechanical pressures acting on the underside of the foot. Preventative offloading treatments including medical grade footwear and personalised insoles are often used to reduce these pressures in an effort to prevent ulceration in people who are determined to be high risk. The research team have developed an approach to 3D print accessible and low-cost personalised metamaterial insoles with functionally graded stiffness that varies across the device. These insoles could potentially be used to enhance the effectiveness of pressure redistribution and prevention of diabetes related foot ulceration. This within-subjects repeated-measures crossover study in healthy participants will compare the immediate effects on plantar pressures in medical grade footwear with personalised 3D printed metamaterial offloading insoles produced using automated design algorithms compared to medical grade footwear with the current standard of care personalised foam insoles. The results of this study will provide insight to the most suitable design algorithms for functionally graded insoles as part of preventative treatment. The findings of this study on healthy participants will inform later studies with participants with Diabetes-related foot ulceration.

The AQUA Pilot Trial is testing whether giving hypotonic fluids (such as 5% glucose or enteral free water) helps critically ill patients with ICU-acquired hypernatraemia (high sodium levels) recover faster compared to usual care. Patients will be randomly assigned to receive either a structured hypotonic fluid protocol or standard treatment to determine which approach leads to quicker sodium normalisation. The study hypothesis is that the protocolised administration of hypotonic fluid will result in a shorter time to normal serum sodium levels (equal or less than 145 mmol/L) compared to usual care. This research aims to help doctors develop better treatment strategies for managing hypernatraemia in intensive care patients, potentially improving outcomes and reducing complications. The trial will also assess safety by monitoring glucose levels, electrolyte balance, and other important clinical measures.

This study will evaluate a new module of text messages designed to support postnatal mental wellbeing, embedded within the Healthy Beginnings for HNEKids (HB4HNEKids) mobile health program. Mental wellbeing in the perinatal period, including positive affect, emotional regulation, social connection, and purpose, is critical for both parents and children but is often overlooked in favour of treating mental illness alone. This two-arm, parallel-group randomised controlled trial will compare the HB4HNEKids program with and without the additional wellbeing module. Participants will be birthing parents, randomly allocated after birth. The primary outcome is parental mental wellbeing at six months postpartum, measured through validated self-report tools.

For this study, participants will have full wound standard-of-care provided by an experienced clinical trial wound nurse, with a wound rinse performed with one of two agents: saline control, or plasma-activated water (PAW). This novel solution has the potential to be a rapid-acting wound cleaning agent that will kill bacteria in biofilm without engendering antibiotic-resistant organisms. As a first-in-human study of a product with a favourable safety profile, we expect this trial to place CALHN researchers and patients at the forefront of new infection control technologies.

Pelvic exenteration is a life-changing surgical procedure for patients with advanced or recurrent pelvic cancers. This procedure is associated with significant postoperative morbidity and increased level of pain. To manage this, oxycodone is currently the mainstay opioid used for postoperative pain control. However, this drug is commonly associated with serious side effects, slowing patient recovery, and increasing the length of hospital stay. A new pain management strategy, using sublingual buprenorphine, may improve outcomes and contribute to better patient recovery. However, the comparative effectiveness of this drug has not been evaluated in a clinical trial. Therefore, we will conduct the first pilot randomised controlled trial, to determine the feasibility and acceptability of administering sublingual buprenorphine when compared to oral oxycodone following pelvic exenteration surgery.

This is a prospective single-arm interventional study evaluating the combined use of the Novoglan medical device and topical corticosteroid (Betamethasone valerate 0.05%) in adult men with phimosis. Participants will be recruited from the Monash Health circumcision waitlist and treated for 8 weeks. The study aims to assess foreskin retractability, symptom improvement, patient satisfaction, treatment adherence, and safety outcomes. Participants will undergo baseline and post-treatment assessments. The ethics application has been submitted to Monash Health HREC and is currently under revision following requested modifications.

This study is evaluating the efficacy and safety of IRX211a for Breakthrough Cancer Pain in Opioid Tolerant Cancer Patients Who is it for? You may be eligible to join this study if you are aged 18 years or above with a current diagnosis of cancer and experiencing breakthrough cancer pain (BTcP - sudden, intense pain that occurs even when a person is already taking regular strong painkillers like opioids) Study details There are 2 parts to this study: a titration phase (Part A) to determine the effective individualised dose for administration in the placebo-controlled RCT phase (Part B). After an initial screening and 14-day baseline observation period, all participants in this study will complete the titration phase where participants receive their initial IRX211a dose (1 mg; 2 actuations administered via a pressurized metered dose inhaler) under medical supervision in-clinic at Day 0. Participants then continue to administer increasing increments of IRX211a (1 actuation per increment) per episode until they reach their effective individualized dose, which is defined as the lowest IRX211a dose that provides adequate pain relief with tolerable side effects across two consecutive BTcP episodes, or until maximum dose of 3.5mg (7 actuations). Participants who cannot identify an effective dose by the end of the 3-week titration period are discontinued. The titration phase will occur over a maximum of 3 weeks. For those participants who establish an effective dose in Part A enter Part B. In Part B, each participant receives 10 numbered pMDI inhalers in a pre-randomized sequence (7 containing active IRX211a and 3 containing matching placebo). Over a period of up to 4 weeks, participants treat one BTcP episode per day using their individualized dose, up to 10 episodes. Pain intensity and relief are recorded before and after each administration at multiple time points. Adherence to the intervention in this study is primarily monitored through a detailed electronic diary (e-Diary) system, patient training, and scheduled follow-up visits. Participants are trained at the screening visit on how to accurately use the study medication (IRX211a inhaler) and complete the e-Diary using a web-based interface. The main goal is to find out whether IRX211a can provide fast and effective pain relief for BTcP. The study hypothesis is that IRX211a will provide better and faster pain relief than placebo when used as an additional treatment for these sudden pain episodes.

This study will evaluate whether using the Stomal Sponge, a soft, absorbent insert placed inside a stoma bag, can help reduce leakage and improve skin health in babies with high-output stomas. The study will be conducted in the Mater Mothers’ Neonatal Critical Care Unit in Brisbane and will involve 15 babies using the Stomal Sponge, compared with a group of 15 similar babies who did not use the sponge in the past. The researchers will measure how often stoma bags need to be changed due to leakage, how long the bags stay in place, and whether the skin around the stoma remains healthy. Parents will also be asked about their experience with stoma care. The Stomal Sponge is already approved for use in Australia and is being used in this study in line with its intended purpose. The study aims to assess its potential clinical benefits in a neonatal hospital setting.

This study is to look at how safe and well tolerated PRX-101 is and to assess how much PRX-101 gets into the blood. PRX-101 is being developed as a possible treatment for paroxysmal supraventricular tachycardia which is a heart condition where the heart suddenly starts beating much faster than normal for a short period of time. The main hypothesis of this study is that PRX-101 is safe and well tolerated in a healthy adult population and that the pharmacokinetic profile (the amount that gets into the blood and how long it takes to be cleared from the body) is the same as that of an intravenous formulation of verapamil hydrochloride. A secondary hypothesis is that PRX-101 will have effects on blood pressure and heart rate.