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Researchers are investigating how exercise might affect treatment outcomes for patients with metastatic colorectal cancer receiving chemotherapy. The study focuses on whether exercise can prevent changes to chemotherapy doses caused by toxicity, improve immune function, and enhance progression-free survival. It also seeks to identify the best type and amount of exercise for these benefits. This is a randomized, multi-arm trial using a Bayesian adaptive design to efficiently compare different exercise programs while minimizing patient exposure to less effective options. Participants are randomly assigned to one of three groups a resistance and continuous aerobic exercise group, an aerobic interval and continuous aerobic exercise group, or a usual care group. Those in the exercise groups engage in supervised moderate-to-high intensity sessions twice a week, plus a third session at home. The exercise includes activities like walking, cycling, and resistance exercises targeting large muscle groups. The usual care group receives standard treatment with exercise guidelines provided. The study uses several interim analyses to potentially stop less effective exercise arms early. During the study, participants undergo regular assessments including chemotherapy dose modifications, progression-free survival, immune cell function, hospitalization, treatment-related toxicities, fitness, muscle strength and mass, quality of life, fatigue, resilience, empowerment, and physical activity levels. These measures are taken from baseline through multiple chemotherapy cycles over several months, with outcomes monitored for up to two years. The study aims to better understand how exercise affects treatment effectiveness and patient well-being in metastatic colorectal cancer.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

Researchers are evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

This research aims to support veterans who experience post-traumatic stress disorder PTSD along with difficulties in managing emotions, aggression, and related challenges. The study focuses on veterans for whom previous treatments have not been effective, offering a specialized aftercare program to help maintain and apply new coping skills over time. The program builds on an earlier 12-week inpatient therapy designed specifically for veterans with complex psychiatric symptoms after active duty missions. Participants will receive hybrid dialectical behavior therapy DBT, which includes face-to-face group skill sessions, individual online sessions, and online homework assignments. All participants follow the same therapy program, but the timing between the initial baseline assessment and the start of the therapy varies randomly. This approach aims to consolidate and reinforce therapy skills learned during prior inpatient treatment. Throughout the study, participants will be monitored from baseline through a follow-up period lasting between 12 to 17 months. Researchers will assess PTSD symptoms and difficulties in emotion regulation using standardized checklists and scales. The study includes ongoing monitoring of participant progress and safety, with the goal of reducing symptom recurrence and improving long-term outcomes for veterans.

Researchers are evaluating whether dexrazoxane can prevent anthracycline-induced cardiac dysfunction AICD in patients with Diffuse Large B Cell Lymphoma DLBCL. Patients treated for DLBCL have a high risk of developing AICD, which causes irreversible heart muscle damage and can lead to heart failure. This trial focuses on DLBCL patients because they receive higher doses of anthracyclines and have a favorable cancer prognosis, making prevention of long-term heart damage especially important. This national, phase III randomized controlled trial includes adults with DLBCL planned to receive six cycles of R-CHOP chemotherapy. Participants are randomly assigned to receive either dexrazoxane intravenously before each doxorubicin infusion or standard R-CHOP treatment without cardioprotective therapy. The trial does not use a placebo due to the nature of dexrazoxane. Cardiac function is monitored with echocardiography before treatment and at 4 and 12 months after starting therapy. Participants will undergo heart function assessments including left ventricular ejection fraction LVEF measurements, along with evaluations of metabolic remission, survival, cardiac biomarkers, and quality of life over 12 months. The study aims to identify patients at highest risk of AICD and confirm that dexrazoxane does not reduce the cancer treatments effectiveness. The total follow-up period is 12 months after the last patient inclusion to assess heart health and treatment outcomes.

Researchers are investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

This research investigates a treatment approach for low-risk breast cancer in female patients aged 50 and above. The study evaluates the effects of a single-dose preoperative partial breast radiotherapy guided by MRI, aiming to measure the rate of complete tumor disappearance at the time of surgery, which occurs between six and twelve months after radiotherapy. Researchers will also monitor tumor response through MRI scans and blood and tumor tissue markers to predict this outcome. Patients receive a single dose of radiotherapy targeting the tumor area, with doses of 20Gy to the gross tumor volume and 15Gy to the clinical tumor volume. Surgery to conserve the breast is planned around 12 months after radiotherapy if MRI shows a complete response. If MRI indicates an incomplete response or disease progression, surgery may be moved earlier, around six months or sooner. During the months between radiotherapy and surgery, MRI scans occur every three months to monitor tumor response. Participants will be assessed regularly using MRI scans and various blood and tissue tests to follow tumor changes and treatment effects. After surgery, patients will be followed for up to 10 years to evaluate cancer outcomes, side effects, cosmetic results, and quality of life. The primary measure is the complete pathological response at 12 months post-radiotherapy, with secondary measures including radiologic response, adverse events, quality of life, cosmetic outcomes, recurrence rates, survival, and biomarkers related to radiotherapy effects.