Prospective, placebo-controlled clinical trial with Aconite Pain Oil in oncological patients under-going chemotherapy to prevent chemotherapy-induced polyneuropathy (CIPN) grade II, to re-duce symptoms typical of CIPN and to improve the quality of life of patients with CIP
- Conditions
- chemotherapy-induced polyneuropathy (CIPN)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-502889-24-00
- Lead Sponsor
- Wala-Heilmittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 350
A consent form, fully dated and signed by the patient and the principal investigator/investigator, is available, Patients with a minimum age of 18 years, Patients with a Karnofsky Index = 70%, Patients with an assumed life expectancy of at least 12 months, Patients with solid tumours, Patients who are scheduled to receive chemotherapy with taxanes or platinum derivatives or their combination for at least 3 months (start of chemotherapy within the next 10 days), Patients of childbearing age must provide a negative pregnancy test
Participation in an interventional trial (with an investigational product) that is concurrent or occurred within 4 weeks prior to inclusion in this trial, Patients with previous or current use of neurotoxic medication (e.g., taxanes, platinum derivatives, metronidazole, isoniazid, amiodarone, vinca alkaloids, checkpoint inhibitors), Patients with the following known comorbidities that predispose them to CIPN: inadequately substituted hypothyroidism, renal insufficiency grade 4 and above, vasculitis/collagenosis, inadequately treated diabetes mellitus, Patients with active and/or clinically relevant infectious diseases: HIV, Lyme disease, hepatitis B/C, herpes infections, Known presence of multiple myeloma or non-Hodgkin’s lymphoma, 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, Patients with metastases in the central nervous system, History of amputation of extremities, Patients with distal muscle weakness and/or atrophy, 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), 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, Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index < 1), 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, Planned acupuncture for the treatment of CIPN during the trial, Topical application of substances such as lidocaine, capsaicin, botulinum toxin, amitriptyline, menthol to hands and/or feet up to 1 week before trial entry (baseline) and application during the trial, Electrotherapy on the extremities up to 1 week before the start of the trial (baseline) and during the trial, Patients treated with topical and/or internally administered medicinal products or cosmetics containing aconite (Aconitum napellus), camphor (Camphora), lavender essential oil (Lavandulae aetheroleum), and/or quartz within 4 weeks prior to inclusion in this trial, Patients with known hypersensitivity to camphor and/or any of the other ingredients of Aconite Pain Oil, as well as peanut or soy, Patients who are not expected to be able to comprehend the significance of the clinical trial, to demonstrate the necessary compliance, and/or to complete the patient questionnaire and patient diary in the German-language for language-related, cognitive, or other reasons, Patients with a planned application of chemotherapy at =4-week intervals, Patients with alcohol/drug/medication dependency, Patients with known genetic predispositions to polyneuropathies, Patients with previous or current polyneuropathy irrespective of cause
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method