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

NCT06186479 | Recruiting Phase 3

• 1 other identifier: kp-acs-2
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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 and therapeutic effects of Aconite pain oil as compared to placebo in oncological patients receiving neurotoxic chemotherapy with taxanes and/or platinum derivatives.

Conditions

Chemotherapy-induced Polyneuropathy

Outcome Measures

Primary Outcomes (2)

• Percentage of CIPN grade II and higher measured by "Common Terminology Criteria for Adverse Events" (CTC-AE v4.0 of 2010)

  for neuralgia, paraesthesia, peripheral motor polyneuropathy, peripheral sensory polyneuropathy

  on average every 3 weeks for max. 27 weeks

• The date of occurrence of CIPN by the principal investigator/investigator using the EORTC-QLQ-CIPN20

  on average every 3 weeks for max. 27 weeks

Study Arms (2)

Verum

EXPERIMENTAL

Drug: Aconite pain oil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aconite pain oil DRUG

Participants apply 6 ml oil topically 2 times per day (morning and evening) for 15 to 27 weeks on chemotherapy-free days as long as they receive chemotherapy.

Verum

Placebo DRUG

Participants apply 6 ml oil topically 2 times per day (morning and evening) for 15 to 27 weeks on chemotherapy-free days as long as they receive chemotherapy.

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index \< 1)
• 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

Sponsors & Collaborators

• WALA Heilmittel GmbH: lead

Study Sites (1)

Medizinische Fakultät Mannheim der Uniklinik Heidelberg

Mannheim, 68167, Germany

RECRUITING

Central Study Contacts

Florian Stintzing, Prof. Dr.

CONTACT

klin-pruef-klifo@wala.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 2, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

DE (1)