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Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying the immediate and long-term effects of structured breathing exercises on mental health symptoms such as anxiety, depression, stress, and sleep quality. The study focuses on healthcare professionals experiencing burnout and aims to assess how these breathing practices might support their mental well-being. This behavioral intervention is sponsored by Mayo Clinic and targets adults aged 18 to 85 years. Participants will engage in self-guided structured breathing sessions lasting 15, 30, or 36 minutes, tailored to their personal skill level. The study monitors the feasibility, acceptability, and appropriateness of these breathing exercises over a four-month period. The intervention is delivered via a mobile app, allowing participants to practice breathing exercises on their own schedule. During the study, participants will be assessed on recruitment ease, retention, mobile app engagement, satisfaction with the breathing intervention, and adherence to the program. Researchers will collect data through mobile app usage metrics and self-reported measures to evaluate how well the intervention fits into the participants routines. The total participation time for each individual is four months, during which their progress and experience with the breathing practice will be closely monitored.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

This research investigates the impact of a team-based kidney care program on adults who have survived moderate to severe acute kidney injury AKI after a hospital stay. The study aims to evaluate how this multidisciplinary approach affects patient-centered outcomes compared to usual care. The goal is to improve recovery and prevent complications after hospital discharge by providing tailored support based on individual risk. Participants are assigned to one of two groups. The intervention group receives risk-based kidney care before leaving the hospital, which may include education, referrals to primary care with medication reviews, or nephrologist-led care combined with remote monitoring for up to 90 days post-discharge. The usual care group receives standard education, laboratory tests, and clinical follow-up after discharge. This pragmatic trial compares these approaches to assess their effects on health outcomes. During the study, participants are monitored for hospital-free days over 90 days, 180 days, and one year. Researchers also track hospital readmissions, death, kidney function changes, recurrence of AKI, chronic kidney disease progression, and cardiovascular events. Follow-up evaluations include laboratory tests, medication reviews, and specialist consultations. The research spans up to one year to assess the long-term effects of the kidney care program on patient health and recovery.

Researchers are evaluating quality of life differences in men with localized prostate cancer treated with two different radiation therapies. The study compares near margin-less adaptive radiation therapy ART, which adapts treatment based on information gathered during therapy and uses smaller margins to limit radiation to healthy tissue, against standard stereotactic ablative body radiotherapy SABR, a precise external radiation delivered over several days. The goal is to see if the shorter ART treatment can provide similar cancer control with fewer side effects impacting quality of life. Participants are randomly assigned to one of two groups one receives near margin-less ART in 2 treatments spaced at least 3 days apart, including imaging with cone beam CT and possibly CT or MRI scans the other receives standard SABR in 5 treatments spaced at least 2 days apart, with CT or MRI imaging. Treatments continue only if there is no disease progression or unacceptable side effects. After treatment, participants are followed with visits at 1, 3, and 6 months, then every 6 months for up to 5 years. Throughout the study, participants complete questionnaires assessing early and late changes in bowel and urinary quality of life, financial impact, erectile function, and prostate symptoms. Researchers also monitor physician-reported toxicities, biochemical markers of cancer progression, and survival. Imaging and dosimetry data are collected to explore treatment effects. This thorough monitoring aims to capture both patient experiences and clinical outcomes over up to 5 years.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab compared to paclitaxel and ramucirumab alone in patients with advanced stomach or esophageal adenocarcinoma. This phase IIIII trial aims to see if nivolumab improves progression-free survival and overall survival in these patients. Nivolumab is an immunotherapy monoclonal antibody that may help the immune system attack cancer, while ramucirumab may prevent tumor blood vessel growth, and paclitaxel stops cancer cells from dividing. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, combined with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives only ramucirumab and paclitaxel on the same schedule without nivolumab. Treatment cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients undergo CT scans and MRI imaging, and may optionally provide blood samples. Throughout the trial, participants are monitored with regular imaging and optional blood tests. After treatment ends, patients have follow-up visits at 30, 60, and 90 days, then every six months for up to three years. Researchers assess progression-free survival, overall survival, response rates, disease control, safety, and quality of life using questionnaires and patient-reported symptoms. This comprehensive monitoring helps evaluate treatment effects and patient well-being over time.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are evaluating the effects of high dose intravenous ascorbic acid combined with chemotherapy in patients with relapsed or refractory lymphomas, clonal cytopenia of undetermined significance CCUS, and chronic myelomonocytic leukemia CMML. This phase II trial aims to determine how ascorbic acid added to standard chemotherapy affects response rates, safety, and survival outcomes compared to chemotherapy alone. The study also explores biological markers related to oxidative stress and DNA methylation to better understand treatment effects. Participants are assigned to different treatment arms based on their disease type. Some receive intravenous ascorbic acid plus combination chemotherapy every 21 days for up to 4 cycles, while others receive placebo with chemotherapy or ascorbic acid alone with varying schedules. Specific regimens include drugs such as rituximab, ifosfamide, carboplatin, etoposide, decitabine, and others, administered intravenously or orally. Some patients undergo stem cell transplantation based on their response. The study includes procedures like blood sample collection, biopsies, echocardiography, PETCT or MRI scans, and central venous line placement. During the study, participants undergo regular assessments to monitor treatment response and side effects. These include imaging scans, bone marrow biopsies, and blood tests to evaluate overall response rates and hematologic improvements. Follow-up visits occur every 3 months initially, then every 6 months after disease progression for up to 2 years. Researchers also collect patient-reported outcomes and monitor safety events throughout the study period to better understand the impact of the treatments being tested.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.