Status:
RECRUITING
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
Lead Sponsor:
WALA Heilmittel GmbH
Conditions:
Chemotherapy-induced Polyneuropathy
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06186479
Start Date
March 13 2024
End Date
August 1 2027
Last Update
September 2 2025
Active Locations (1)
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1
Medizinische Fakultät Mannheim der Uniklinik Heidelberg
Mannheim, Germany, 68167