- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06186479
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
April 5, 2024 updated by: WALA Heilmittel GmbH
Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent Grade-II Chemotherapy-induced Polyneuropathy (CIPN), to Reduce Symptoms Typical of CIPN, and to Improve the Quality of Life of Patients With CIPN
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
350
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Florian Stintzing, Prof. Dr.
- Email: klin-pruef-klifo@wala.de
Study Locations
-
-
-
Mannheim, Germany, 68167
- Recruiting
- Medizinische Fakultät Mannheim der Uniklinik Heidelberg
-
Contact:
- R.-D. Hofheinz, Prof. Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 (start of chemotherapy within the next 10 days)
- 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 use of neurotoxic medication (e.g., taxanes, platinum derivatives, metronidazole, isoniazid, amiodarone, vinca alkaloids, checkpoint inhibitors)
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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.
|
Experimental: Verum
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of CIPN grade II and higher measured by "Common Terminology Criteria for Adverse Events" (CTC-AE v4.0 of 2010)
Time Frame: on average every 3 weeks for max. 27 weeks
|
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
Time Frame: on average every 3 weeks for max. 27 weeks
|
on average every 3 weeks for max. 27 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
December 29, 2023
First Posted (Actual)
January 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kp-acs-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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