[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chemotherapy-toxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chemotherapy-toxicity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100633295","telenursing-for-the-early-detection-and-management-of-side-effects-associated-with-cyclin-dependent-kinase-inhibitors-in-breast-cancer-patients-100633295",false,"NCT07524829","Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients","NURSING-Preeffect: Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients","Inclusion Criteria:\n\n* Female patients aged ≥18 years\n* Histologically confirmed breast cancer\n* Ongoing treatment with CDK 4\u002F6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib)\n* Ability to understand and provide informed consent\n* Access to a telephone or digital communication device for telenursing follow-up\n\nExclusion Criteria:\n\n* Inability to comply with the study procedures\n* Cognitive impairment or psychiatric conditions interfering with participation\n* Participation in another interventional clinical trial that may affect study outcomes\n* Severe comorbidities limiting life expectancy or follow-up","FEMALE","18 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a multicenter randomized controlled trial designed to evaluate the effectiveness of a structured telenursing intervention in patients with breast cancer receiving cyclin-dependent kinase (CDK) inhibitor therapy.\n\nPatients undergoing treatment with CDK inhibitors frequently experience adverse effects that may negatively impact treatment adherence, quality of life, and clinical outcomes. Early detection and timely management of these side effects are essential to optimize therapy and reduce complications, including unplanned hospitalizations and treatment interruptions.\n\nIn this study, participants are randomly assigned to one of two groups: standard care or standard care plus a structured telenursing follow-up program. The intervention consists of scheduled remote contacts (telephone or video consultations) conducted by trained nursing staff at predefined time points during treatment. These contacts aim to monitor symptoms, provide education, reinforce adherence, and facilitate early identification and management of treatment-related toxicities.\n\nThe primary objective of the study is to assess whether the telenursing intervention reduces the incidence and severity of treatment-related adverse events compared to standard care alone. Secondary objectives include evaluating its impact on emergency department visits, hospitalizations, treatment adherence, dose intensity, and patient-reported outcomes.\n\nThe study is currently recruiting participants across multiple centers. Results from this trial may provide evidence to support the integration of structured telenursing programs into routine oncology care, with the potential to improve patient safety, treatment continuity, and overall clinical outcomes.",[26,27,28,29,30],"Breast Cancer","Drug-Related Side Effects and Adverse Reactions","Chemotherapy Toxicity","Treatment Adherence","Treatment-Related Toxicity",[26,32,33,34,35,36,37,38,29,39],"Telenursing","Telemedicine","Cyclin-Dependent Kinase Inhibitors","CDK4\u002F6 Inhibitors","Treatment Toxicity","Adverse Events","Supportive Care","Oncology Nursing","RECRUITING","2026-04-09",{"date":43,"type":44},"2026-04-13","ACTUAL",{"date":46,"type":44},"2024-04-09",{"date":48,"type":20},"2028-09",{"name":50,"class":51},"Azienda Sanitaria Locale di Asti","OTHER_GOV",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":76,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":5},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.",{"count":62,"type":20},38,"4 Months","OBSERVATIONAL","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[67,68,28,69,70,71,72,73,74,75],"Pelvic Toxicity","Radiation Toxicity","Gynecological Tumors","Radiation Proctitis","Radiation Cystitis","Vaginal Mucositis","Vulvar Mucositis","Quality of Life","Dysbiosis",[77,78,79,80,81,82,83,84,85,86,75],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Radiotherapy","Chemotherapy","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","NOT_YET_RECRUITING","2025-12-16",{"date":90,"type":44},"2025-12-22",{"date":92,"type":20},"2026-01-15",{"date":94,"type":20},"2028-03-31",{"name":96,"class":97},"Bernardino Clavo, MD, PhD","OTHER"]