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

Exclusion Criteria

• •1. Participation in an interventional trial (with an investigational product) that is concurrent or occurred within 4 weeks prior to inclusion in this trial
• •2. Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index \< 1)
• •3. 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
• •4. Patients with known hypersensitivity to camphor and/or any of the other ingredients of Aconite Pain Oil, as well as peanut or soy
• •5. 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
• •6. Patients with a planned application of chemotherapy at ≥4-week intervals
• •7. Patients with alcohol/drug/medication dependency
• •8. Patients with known genetic predispositions to polyneuropathies
• •9. Patients with previous or current polyneuropathy irrespective of cause
• •10. 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/or platinum derivative administration
• •11. 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
• •12. Patients with active and/or clinically relevant infectious diseases: HIV, Lyme disease, hepatitis B/C, herpes infections
• •13. Known presence of multiple myeloma or non-Hodgkin's lymphoma
• •14. 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
• •15. Patients with metastases in the central nervous system
• •16. History of amputation of extremities
• •17. Patients with distal muscle weakness and/or atrophy
• •18. 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)
• •19. 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
• •20. 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
• •21. Planned acupuncture for the treatment of CIPN during the trial
• •22. 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
• •23. Electrotherapy on the extremities up to 1 week before the start of the trial (baseline) and during the trial