Actively 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
Led by WALA Heilmittel GmbH · Updated on 2025-09-02
350
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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/or platinum derivatives.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated consent form from patient and investigator
- Age 18 years or older
- Karnofsky Index of 70% or higher
- Life expectancy of at least 12 months
- Diagnosis of solid tumors
- Scheduled for unmodified chemotherapy with taxanes or platinum derivatives or both for at least 3 months
- Negative pregnancy test for patients of childbearing age
You will not qualify if you...
- Participation in another interventional trial within 4 weeks before this study
- Pregnant, breastfeeding, or not using effective contraception
- Use of topical or internal products containing aconite, camphor, lavender oil, or quartz within 4 weeks
- Known allergy to camphor, any ingredient of Aconite Pain Oil, peanut, or soy
- Inability to understand or comply with the trial or complete questionnaires in German
- Planned chemotherapy with intervals of 4 weeks or more
- Dependency on alcohol, drugs, or medication
- Known genetic risk for polyneuropathies
- Previous or current polyneuropathy from any cause
- Use of neurotoxic medication outside planned chemotherapy affecting study endpoints
- Comorbidities predisposing to CIPN such as untreated hypothyroidism, advanced renal insufficiency, vasculitis, or uncontrolled diabetes
- Active or relevant infections including HIV, Lyme disease, hepatitis B/C, herpes infections
- Diagnosed multiple myeloma or non-Hodgkin's lymphoma
- Neurological diseases like Alzheimer's, multiple sclerosis, Parkinson's that interfere with endpoint assessment
- Central nervous system metastases
- History of limb amputation
- Distal muscle weakness or atrophy
- Skin lesions or conditions preventing use of the investigational product on extremities
- Serious acute or chronic illnesses impairing trial participation
- Use of co-analgesics like gabapentin, pregabalin, certain antidepressants 1 week before and during trial before CIPN grade III
- Planned acupuncture for CIPN treatment during trial
- Use of topical agents like lidocaine, capsaicin, botulinum toxin, or menthol on hands/feet 1 week before and during trial
- Electrotherapy on extremities 1 week before and during trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medizinische Fakultät Mannheim der Uniklinik Heidelberg
Mannheim, Germany, 68167
Actively Recruiting
Research Team
F
Florian Stintzing, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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