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Researchers are investigating how exercise affects patients with metastatic colorectal cancer receiving chemotherapy. The study explores whether exercise can prevent chemotherapy dose changes caused by treatment side effects, improve immune function, and ultimately enhance progression-free survival. The trial also seeks to determine the best type and dose of exercise to recommend, as current evidence on optimal exercise prescription is limited. Using a Bayesian adaptive design allows for more efficient evaluation by potentially dropping less effective exercise programs early. Participants will be randomly assigned to one of three groups: resistance exercise, aerobic interval exercise, or usual care without a specific exercise program. The exercise interventions involve continuous aerobic and resistance exercises or continuous aerobic and aerobic interval exercises. These programs aim to reduce chemotherapy toxicity and improve psychological and physical strength. The study uses a multi-arm multi-stage design with interim analyses to select the most beneficial exercise prescription while minimizing patient exposure to less effective treatments. Throughout the study, participants will be monitored for chemotherapy dose modifications and progression-free survival for up to two years. Assessments include tracking chemotherapy dose adjustments during treatment cycles, immune function by evaluating natural killer cells, and quality of life measures. Researchers will also observe treatment-related toxicities and hospitalizations. The trial aims to provide evidence on how exercise can support chemotherapy effectiveness and improve outcomes in metastatic colorectal cancer patients.

Researchers are evaluating the use of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in people who have experienced transient atrial fibrillation episodes triggered by stress and have additional risk factors for stroke. This multinational, investigator-initiated Phase 4 trial aims to prevent stroke and other serious cardiovascular events in this group by assessing the effects of NOACs on two main outcomes: the occurrence of non-hemorrhagic stroke or systemic embolism, and a combination of vascular death and other major cardiovascular problems, over a follow-up period lasting until the last participant reaches 24 months of observation. Participants in the study are randomly assigned to either receive one of several NOAC medications—edoxaban, apixaban, dabigatran, or rivaroxaban—with dosing adjusted as needed and chosen by their prescribing doctor, or to receive no oral anticoagulation. The treatment continues throughout the follow-up period. The trial is open-label, meaning both researchers and participants know which treatment is given. The study specifically focuses on patients who had transient atrial fibrillation related to stress, such as after certain surgeries or acute medical illness. During the study, participants undergo regular monitoring to track the incidence of stroke, embolism, vascular death, heart attacks, blood clots, and other cardiovascular events. Researchers collect information over up to two years to evaluate these outcomes. Safety and adherence to treatment are also monitored. This thorough follow-up helps determine the impact of NOAC treatment compared to no anticoagulation in this particular patient population.

Researchers are evaluating two types of cognitive-behavioral therapy (CBT) for adults aged 18 and older with anxiety-related disorders, including panic disorder, agoraphobia, generalized anxiety disorder, social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, and health anxiety disorder. The study aims to determine whether brief-intensive CBT leads to faster and better improvement in daily functioning such as work and family life compared to regular weekly CBT. This is a parallel-group randomized controlled trial conducted in multiple centers. Participants will receive either brief-intensive CBT, consisting of 16 exposure therapy sessions delivered over 4 half-days within 2 weeks plus 4 follow-up sessions within 3 months, or regular CBT consisting of 20 weekly sessions over 6 months. Both treatment approaches include 20 sessions of 45 minutes each and can be personalized to focus on improving work or family functioning. This trial compares the effects and feasibility of these two treatment schedules. During the 1-year study, participants will complete seven assessments lasting about 5 hours total, including online questionnaires and telephone interviews. These will evaluate health, disability, quality of life, anxiety and depression symptoms, coping strategies, and therapy expectations. The main outcome is the change in health and disability over 6 months. Additional measures include treatment effectiveness after 1 year, cost-effectiveness, and participants' preferences and drop-out rates.

Researchers are evaluating chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are investigating whether dexrazoxane can prevent anthracycline-induced cardiac dysfunction (AICD) in adult patients with diffuse large B-cell lymphoma (DLBCL) receiving first-line treatment. Patients treated for DLBCL have a higher risk of developing heart damage and heart failure due to anthracycline chemotherapy, with a reported cumulative incidence of 5-10% within five years and even higher rates in elderly patients. The study aims to identify those at highest risk of AICD while ensuring that dexrazoxane does not reduce the effectiveness of cancer treatment. This phase III national trial will enroll 324 patients across 25 Dutch hospitals who are planned to receive six cycles of R-CHOP chemotherapy, including doxorubicin. Participants will be randomly assigned to receive either intravenous dexrazoxane before each doxorubicin infusion or no cardioprotective treatment. Dexrazoxane will be given at a 10:1 ratio to doxorubicin and infused 30 minutes prior to the chemotherapy. Additional drugs given as part of R-CHOP include rituximab, cyclophosphamide, vincristine, and prednisolone. Some patients with double hit lymphoma may also receive lenalidomide. Supportive treatment with pegfilgrastim will be provided if needed. Participants will have their heart function assessed by echocardiography before starting chemotherapy and at 4 and 12 months after randomization. The main outcome is the incidence of AICD, defined by a significant decline in heart pumping ability. Researchers will also measure complete metabolic remission to confirm that dexrazoxane does not interfere with cancer treatment. The study includes detailed monitoring of patient and treatment factors to better predict AICD risk. Total participation lasts at least 12 months post-treatment initiation.

Researchers are studying patients diagnosed with colorectal cancer, small bowel cancer, and anal cancer to better understand factors that affect treatment outcomes and survival. This study looks beyond tumor stage to explore how biochemical, genetic, environmental, and clinical factors may influence tumor recurrence and patient survival. It aims to address the gap in knowledge caused by most cancer patients not participating in clinical trials, and to validate trial results in a broader patient population. This is a prospective observational cohort study where data is collected from patients starting at their primary diagnosis and continuing until death. After informed consent, researchers gather detailed information on medical history, clinical status, imaging, pathology, tumor characteristics, treatments, hospital stays, side effects, and adverse events. Additional consent allows collection of patient-reported outcomes on quality of life and work ability, as well as biological materials like blood and tumor tissue for research and biobanking. Participants will be closely followed over time with ongoing data collection on treatment effects, clinical outcomes, and patient experiences. The study aims to provide accurate real-world data on various treatments and outcomes and to serve as a resource for future research into prognostic markers, new therapies, molecular studies, and health care policy. The main outcome measured is progression-free survival, tracked for up to 10 years, to better understand long-term treatment impact.

Researchers are evaluating the use of MRI-guided single-dose preoperative partial breast radiotherapy in women aged 50 and older with low-risk breast cancer to study the rate of complete tumor disappearance after treatment. This trial focuses on patients with unifocal cT1N0 breast cancer who are ER positive and HER2 negative, aiming to predict tumor response using MRI scans and markers in blood and tumor tissue. The study is designed to assess how well tumors respond to this radiotherapy approach over an interval of six to twelve months before surgery. Participants receive a single dose of radiotherapy delivering 20Gy to the gross tumor volume and 15Gy to the clinical tumor volume before surgery. Breast conserving surgery is scheduled 12 months after radiotherapy if MRI scans show complete radiologic response. If response is incomplete, surgery occurs at 6 months, or sooner if the tumor progresses. MRI scans are performed every 3 months between radiotherapy and surgery to monitor tumor response. During the study, patients undergo regular MRI scans and tumor marker assessments to track treatment effect. After surgery, follow-up continues for up to 10 years to evaluate cancer outcomes, side effects, cosmetic results, and quality of life. The primary outcome measured is the pathologic complete response 12 months after radiotherapy, reflecting the absence of cancer cells in the tissue removed during surgery.