[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"WALA Heilmittel GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100530415","phase-3-clinical-trial-with-aconite-pain-oil-in-oncology-patients-under-chemotherapy-to-prevent-cipn-grade-ii-to-reduce-symptoms-and-to-improve-the-quality-of-life-of-patients-with-cipn-100530415",false,"NCT06186479","Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent CIPN Grade-II, to Reduce Symptoms and to Improve the Quality of Life of Patients With CIPN","Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent Grade-II Chemotherapy-induced Polyneuropathy (CIPN), to Reduce Symptoms Typical of CIPN, and to Improve the Quality of Life of Patients With CIPN","Inclusion Criteria:\n\n1. A consent form, fully dated and signed by the patient and the principal investigator\u002Finvestigator, is available\n2. Patients with a minimum age of 18 years\n3. Patients with a Karnofsky Index ≥ 70%\n4. Patients with an assumed life expectancy of at least 12 months\n5. Patients with solid tumours\n6. Patients who are scheduled to receive unmodified chemotherapy with taxanes or platinum derivatives or their combination approved in Germany for at least 3 months (3 lunar months \u002F 12 weeks)\n7. Patients of childbearing age must provide a negative pregnancy test\n\nExclusion Criteria:\n\n1. Participation in an interventional trial (with an investigational product) that is concurrent or occurred within 4 weeks prior to inclusion in this trial\n2. Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index \\\u003C 1)\n3. Patients treated with topical and\u002For internally administered medicinal products or cosmetics containing aconite (Aconitum napellus), camphor (Camphora), lavender essential oil (Lavandulae aetheroleum), and\u002For quartz within 4 weeks prior to inclusion in this trial\n4. Patients with known hypersensitivity to camphor and\u002For any of the other ingredients of Aconite Pain Oil, as well as peanut or soy\n5. Patients who are not expected to be able to comprehend the significance of the clinical trial, to demonstrate the necessary compliance, and\u002For to complete the patient questionnaire and patient diary in the German-language for language-related, cognitive, or other reasons\n6. Patients with a planned application of chemotherapy at ≥4-week intervals\n7. Patients with alcohol\u002Fdrug\u002Fmedication dependency\n8. Patients with known genetic predispositions to polyneuropathies\n9. Patients with previous or current polyneuropathy irrespective of cause\n10. Patients with previous or current neurotoxic medication outside the planned chemotherapy protocol that has an impact on the primary endpoint (at the investigator´s discretion) and prior taxane and\u002For platinum derivative administration\n11. Patients with the following known comorbidities that predispose them to CIPN:\n\n    inadequately substituted hypothyroidism, renal insufficiency grade 4 and above, vasculitis\u002Fcollagenosis, inadequately treated diabetes mellitus\n12. Patients with active and\u002For clinically relevant infectious diseases: HIV, Lyme disease, hepatitis B\u002FC, herpes infections\n13. Known presence of multiple myeloma or non-Hodgkin's lymphoma\n14. Present neurological diseases, Alzheimer's disease, multiple sclerosis, Parkinson's disease, and other neurological diseases that make it difficult or impossible to assess the primary endpoint according to the investigator's opinion\n15. Patients with metastases in the central nervous system\n16. History of amputation of extremities\n17. Patients with distal muscle weakness and\u002For atrophy\n18. Skin lesions or other findings in the area of the extremities that make it impossible to use the investigational product (e.g., hand-foot syndrome)\n19. Presence of any other serious acute or chronic organic or mental illness with severe impairment of the general condition that impairs or prevents regular participation in the trial\n20. Use of co-analgesics such as gabapentin, pregabalin, amitriptyline, nortriptyline, clomipramine, imipramine, duloxetine 1 week before commencement of the trial (baseline) and intake during the trial before reaching CIPN grade III\n21. Planned acupuncture for the treatment of CIPN during the trial\n22. Topical application of substances such as lidocaine, capsaicin, botulinum toxin, amitriptyline, menthol to hands and\u002For feet up to 1 week before trial entry (baseline) and application during the trial\n23. Electrotherapy on the extremities up to 1 week before the start of the trial (baseline) and during the trial","ALL","18 Years","100 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The clinical trial is planned as a prospective, multicentre, blinded, randomised, placebo-controlled, national clinical trial in Germany. The clinical trial is designed for testing the prophylactic and therapeutic effects of Aconite pain oil as compared to placebo in oncological patients receiving neurotoxic chemotherapy with taxanes and\u002For platinum derivatives.",[27],"Chemotherapy-induced Polyneuropathy","RECRUITING","2025-08-25",{"date":31,"type":32},"2025-09-02","ACTUAL",{"date":34,"type":32},"2024-03-13",{"date":36,"type":21},"2027-08-01",{"name":38,"class":39},"WALA Heilmittel GmbH","OTHER",""]