Baxter

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are not eligible for stem cell transplant and are considered frail or intermediate-fit based on age, other health conditions, and functional status. This phase III trial compares three induction regimens followed by either single or double maintenance therapy to see which combination works best to control the cancer and improve survival. The study also examines patient quality of life, safety, and other treatment effects over time. Patients are randomly assigned to one of three treatment groups. The first group receives bortezomib, lenalidomide, and dexamethasone for up to nine 28-day cycles, followed by lenalidomide maintenance. The second group receives daratumumab and hyaluronidase-fihj, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. The third group has the same induction as the second group but receives both daratumumab and lenalidomide during maintenance. Treatments are given by injection or orally on specific days within each cycle, and continue as long as the disease does not progress or side effects are unacceptable. Participants undergo assessments including tumor measurements, blood tests, patient-reported questionnaires, and blood sample banking for future research. After completing treatment, patients are followed up every three months for one year, then every six months for two years, and annually for up to ten years to monitor progression, survival, and quality of life. The main outcomes measured are progression-free survival and overall survival, with additional evaluations of response rates, safety, and symptom reports up to ten years after starting the study.

Researchers are evaluating whether adding the chemotherapy drug Docetaxel to the usual hormone treatments can better control metastatic castration sensitive prostate cancer (mCSPC) in patients who have not responded optimally to initial hormone therapy. This phase III randomized trial compares the combination of Docetaxel, Androgen Deprivation Therapy (ADT), and Androgen-Receptor Pathway Inhibitors (ARPI) to the usual treatment of ADT plus ARPI alone. The study focuses on men with a suboptimal PSA response after 6 to 12 months of androgen-targeting therapy. Participants will be randomly assigned to either continue with standard hormone therapy involving ADT and ARPI drugs such as abiraterone, enzalutamide, apalutamide, or darolutamide, or to receive Docetaxel chemotherapy added to this standard treatment. The treatments are given according to physician choice and prior assignment, with Docetaxel being introduced at enrollment for the experimental group. The study is open-label and conducted at multiple international centers. During the trial, participants will be monitored for overall survival over 39 months, along with PSA progression, PSA response, PSA kinetics, and clinical progression-free survival. Researchers will assess these outcomes to compare the two treatment approaches. Participants must be available for treatment and follow-up visits as scheduled, with regular testing of PSA levels, testosterone, organ function, and adverse event monitoring to ensure safety and evaluate treatment effects.

Researchers are studying hair loss caused by endocrine therapy in both postmenopausal and premenopausal women with breast cancer. Hair loss is a common and distressing side effect of cancer treatments, and this study aims to better understand how often it occurs, its timing, duration, and severity, especially related to different types of endocrine therapies. The study compares women receiving tamoxifen, aromatase inhibitors, aromatase inhibitors with CDK4/6 inhibitors, and those not receiving endocrine therapy. This observational study involves patients completing questionnaires and surveys about their hair loss. Medical records will also be reviewed to gather information. The study includes four main groups of postmenopausal women and a premenopausal group that has already completed enrollment. Participants answer questions every three months, starting within two weeks of beginning endocrine therapy or CDK4/6 inhibitor treatment. Participants will provide detailed reports about their hair loss symptoms and complete regular surveys to measure the impact on quality of life. Researchers will analyze patient-reported data on hair loss incidence and severity up to two years. The study helps characterize treatment-related alopecia and its effects, supporting better understanding of this side effect during breast cancer therapy.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

Researchers are studying the effects of social and genetic factors on the health outcomes of adolescent and young adult (AYA) cancer survivors who had Hodgkin or non-Hodgkin lymphoma. This observational study aims to understand how these factors influence disease-free survival, overall survival, and quality of life in this group, which faces unique risks compared to older or childhood cancer patients. The study also explores how gene expression changes might mediate these effects and considers the impact of race, gender identity, and location. Participants will complete questionnaires about their health-related quality of life and provide blood samples at the start of the study and then at 6, 12, 18, and 24 months. These activities will help researchers gather information on social-environmental risk factors, individual resilience, and biological changes. The study does not involve any treatment but focuses on monitoring and collecting data over two years. During the study, participants will be asked to complete quality of life questionnaires and give blood samples multiple times. Researchers will track disease-free survival, overall survival, and any other health complications up to two years. The study includes careful monitoring of participants' health status and aims to provide insights that could help improve care for young cancer survivors. Participation requires internet access and the ability to complete forms in English, with informed consent obtained from each participant or their representative.

Researchers are evaluating an online educational program called Current Together After Cancer (CTAC) to see if it helps colorectal cancer survivors who had surgery receive follow-up care that matches current guidelines. This phase III trial focuses on patients with stage II or III colorectal cancer who have had their tumors surgically removed. The study aims to improve patients' knowledge about surveillance, their confidence in managing follow-up care, and satisfaction with the involvement of a supporter in their care. Patients in the trial are randomly assigned to one of two groups. One group and their supporter get access to the CTAC intervention website, which contains educational content and interactive modules related to colorectal cancer surveillance. The other group and their supporter receive access to a general health education website. Participants may review their assigned website as often as they like for up to 16 months. During the study, participants will complete questionnaires at baseline, 3 months, and 16 months to assess knowledge, self-efficacy, cancer worry, preferences, and satisfaction with supporter engagement. Researchers will measure whether patients receive colorectal cancer surveillance aligned with guidelines at 16 months. The study also explores how supporters' participation relates to patient outcomes. Participants may be contacted via email or phone for study activities and are encouraged to complete all scheduled assessments.

This research aims to assess colorectal cancer rates in participants aged 45 to 70 who have 1 to 2 non-advanced adenomatous polyps. The study compares the outcomes of surveillance colonoscopy performed once at 10 years versus twice at 5 and 10 years after the initial colonoscopy. Colorectal cancer is a common and serious disease, and while colonoscopy screening reduces its incidence, the best timing for follow-up exams after finding small non-advanced adenomas is unclear. Participants are randomly assigned to one of two groups: one group receives surveillance colonoscopies at both 5 and 10 years after the qualifying colonoscopy, and the other group receives a single surveillance colonoscopy at 10 years. Colonoscopies follow standard quality guidelines and preparation instructions. All polyps found during the initial colonoscopy must have been completely removed for participants to be eligible. Throughout the study, participants will undergo colonoscopies according to their group assignment and will be monitored for the development of colorectal cancer over 10 years. Researchers will evaluate the incidence of colorectal cancer as the primary outcome. Participants' adherence to scheduled colonoscopies and any additional procedures will be tracked. This study is designed to provide clear evidence on the optimal timing of surveillance colonoscopy after detection of small adenomas, informing future guidelines and clinical practice.

Researchers are evaluating the use of lanreotide before surgery compared to surgery alone to prevent pancreatic fistulas in patients with pancreatic cancer or pancreatic lesions that might become cancerous. This phase III trial aims to see if lanreotide, a drug similar to the body's hormone somatostatin and used in certain tumors, can reduce complications like pancreatic fistulas after distal pancreatectomy surgery. Participants are randomly assigned to receive either lanreotide or a saline placebo by a quick injection under the skin within 36 hours before their planned distal pancreatectomy. Blood samples will be taken before surgery and on the first and third days after surgery, with possible collection of pancreatic fluid on these days as well. After surgery, patients will be followed up at 4, 8, and 12 months. During the study, researchers will assess the occurrence of pancreatic fistulas within 60 days after surgery, hospital stay length, and quality of life changes using specific questionnaires. They will also monitor other postoperative complications and the time to start any additional chemotherapy. Blood, pancreatic fluid, and tissue samples will be collected for future research, with all participants monitored carefully throughout the study period.