Bundaberg Central

Researchers are studying women with a newly diagnosed invasive breast cancer that is node negative and 3 cm or smaller in size to compare two types of radiation therapy after breast-conserving surgery BCS. The study aims to see if partial breast irradiation PBI given once daily over one week is not worse than whole breast irradiation WBI in preventing cancer return and whether it results in better cosmetic outcomes. This is a randomized, single-blind trial focusing on local recurrence and patient-assessed cosmesis three years after treatment. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total of 26 Gy radiation in 5 fractions, given once daily over 5 to 7 days with up to 8 days allowed for scheduling reasons. PBI targets the tumor bed plus a margin of normal tissue, while WBI targets the whole breast. Patients will not know which treatment they receive to avoid bias in cosmetic assessments. Stratification factors include tumor size, estrogen receptor status, and clinical center. During the study, participants will be monitored for local recurrence annually for five years and will assess their cosmetic outcome at three and five years post-treatment. Researchers will also evaluate survival, disease-free survival, radiation side effects, and quality of life at various intervals. Clinical assessments and nurse evaluations of cosmesis will occur at three and five years. Overall, participant involvement spans several years with multiple follow-up visits to measure outcomes and safety.

Researchers are studying an experimental drug called fianlimab combined with cemiplimab, comparing it to cemiplimab combined with a placebo, in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been previously treated. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the study drugs, which could affect their action or cause side effects. Participants are divided into two groups based on HPV status and randomized to receive either the fixed-dose combination of fianlimab and cemiplimab or cemiplimab plus placebo. Approximately 60 participants each with HPV-positive and HPV-negative HNSCC will be enrolled. The drugs are administered according to the study protocol, and participants receive treatment as part of this randomized, phase II trial. During the study, participants will be monitored for treatment response, side effects, and drug levels in their blood. Researchers will assess overall response rates and various adverse events up to 90 days after the last treatment and for approximately 58 months total. Safety, disease control, progression, and immune responses will be closely evaluated throughout the study period.

Researchers are evaluating several treatments for adults with kidney failure who have recently been diagnosed with calciphylaxis, a rare disease affecting about 1 to 2 people in 10,000. This phase 3 global platform trial aims to provide high-quality evidence on the effects of different therapies across various care areas. The study uses an adaptive design to add or remove treatment options based on ongoing results, improving how patients with this condition are treated. The trial begins with two main treatment areas the Dialysis Membrane Domain and the Pharmacotherapy Domain. In the Pharmacotherapy Domain, participants receive either Vitamin K1 capsules, Magnesium Citrate tablets, Sodium Thiosulfate injections, or placebos, with dosing schedules matched to their dialysis sessions. The Dialysis Membrane Domain compares two types of dialysis filters, high flux and medium cut-off dialysers, in an open-label design. Treatments are given according to these schedules, and new interventions may be added as the trial progresses. Participants will be monitored and assessed using the BEAT-Calci Wound Assessment Scale over 12 weeks as the primary outcome, with additional evaluations up to 26 weeks and beyond. Assessments include wound measurements, pain levels, analgesic use, quality of life, infection rates, hospital days, mortality, kidney transplantation status, and calciphylaxis recurrence. The study uses a Bayesian adaptive approach to adjust sample size and study arms based on collected data, continuing until clear results on treatment effects are reached.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating whether metformin, a medication commonly used for diabetes, can be repurposed to slow kidney function decline in adults diagnosed with early-stage Autosomal Dominant Polycystic Kidney Disease ADPKD. ADPKD causes cyst growth in kidneys leading to pain, high blood pressure, chronic kidney disease, and reduced quality of life. This global Phase III randomized controlled trial aims to find effective, affordable treatments to reduce illness impact and improve life quality for ADPKD patients. Participants are randomly assigned to receive either extended-release metformin Metformin XR or a placebo, alongside standard care, for 104 weeks. The metformin dose ranges from 500 to 2000 mg daily based on individual tolerance and kidney function. The study includes a control group receiving identical placebo tablets for comparison. This design allows assessment of metformins effect on slowing disease progression. During the study, participants undergo regular monitoring including kidney function tests, assessment of kidney disease progression, quality of life questionnaires, and tracking of side effects and healthcare use over 24 months. The primary outcome is the change in estimated glomerular filtration rate eGFR. Secondary outcomes include kidney failure, mortality, medication dosing changes, and symptoms related to ADPKD. Safety and effectiveness are carefully followed throughout the trial period, which may last until 2030.

Kidney failure is a serious health problem that requires treatment with dialysis or transplantation to survive. Haemodialysis, the most common treatment, can cause symptoms like fatigue, pain, cramps, and poor quality of life, with less than 60% of full health reported by patients. Early mortality rates are high, especially in the first 3 to 6 months after starting haemodialysis at the usual three sessions per week. This trial investigates whether starting haemodialysis incrementally at two sessions per week preserves quality of life and kidney function better than conventional treatment. The study compares two approaches incremental haemodialysis, where participants begin with two sessions per week and increase to three sessions only if needed, and conventional haemodialysis, where participants start with three sessions per week from the beginning. This randomized, open-label trial will recruit 372 participants across centers in Australia and Canada. The goal is to assess if the incremental method is a safe, practical, and cost-effective alternative that reduces the physical and financial burdens of dialysis. Participants will be followed for up to 18 months, with quality of life assessed at 6 months using the Kidney Disease Quality of Life Short Form questionnaire as the primary measure. Additional assessments include kidney function, healthcare use and costs, mortality, hospital admissions, symptoms, fatigue, nutritional status, and vascular access, collected at regular intervals. The study will monitor safety and side effects throughout the trial period to provide comprehensive data on the impacts of both dialysis approaches.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are conducting a prospective observational study to understand the natural progression of coronary plaque buildup in people with melanoma who are treated with immune checkpoint inhibitors ICIs. The study focuses on assessing coronary atherosclerosis and cardiovascular risk factors in this population. It is sponsored by Monash University and takes place across several sites in Australia. Participants are observed without any experimental treatments being administered by the study. The study evaluates how statin use relates to the amount and progression of coronary artery disease in patients treated with ICIs. The study also looks at the effects of using CT coronary angiography CTCA to guide preventive statin therapy. Various outcomes are assessed over an 18-month period. During the study, participants undergo imaging tests such as CTCA and assessments of their cardiovascular risk factors and quality of life. Researchers will track major cardiovascular events, melanoma progression-free survival, and overall survival. The study requires follow-up visits and imaging, and participants are monitored for up to 18 months to gather these data.