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

Inclusion criteria

• 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 unmodified chemotherapy with taxanes or platinum derivatives or their combination approved in Germany for at least 3 months (3 lunar months / 12 weeks)
• Patients of childbearing age must provide a negative pregnancy test

Exclusion criteria

• Participation in an interventional trial (with an investigational product) that is concurrent or occurred within 4 weeks prior to inclusion in this trial
• Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index < 1)
• 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
• 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
• 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
• 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