Chemotherapy-induced PolyneuropathyPhase 3NCT06186479
Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent CIPN, to Reduce Symptoms and to Improve the Quality of Life of Patients With CIPN
A Phase 3 study testing Aconite pain oil in people with Chemotherapy-induced Polyneuropathy, run by WALA Heilmittel GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chemotherapy-induced Polyneuropathy
- What is being tested?
- Aconite pain oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- 13 Mar 2024to 1 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Medizinische Fakultät Mannheim der Uniklinik Heidelberg
Mannheim, 68167
R.-D. Hofheinz, Prof. Dr.
About this study
Official title: Clinical Trial With Aconite Pain Oil in Oncological Patients Undergoing Chemotherapy to Prevent 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.
- Conditions
- Chemotherapy-induced Polyneuropathy
- Being tested
- Aconite pain oil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aconite pain oilDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Not described Receives: Drug: Aconite pain oil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CIPN measured by "Common Terminology Criteria for Adverse Events" (CTC-AE v4.0 of 2010)
for neuralgia, paraesthesia, peripheral motor polyneuropathy, peripheral sensory polyneuropathy
Measured: 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
Measured: on average every 3 weeks for max. 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start13 Mar 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WALA Heilmittel GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186479
- Sponsor's protocol ID
- kp-acs-2
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial With Aconite Pain Oil in Oncological Patients Undergoing Chemotherapy to Prevent Chemotherapy-induced Polyneuropathy (CIPN), to Reduce Symptoms Typical of CIPN and to Improve the Quality of Life of Patients With CIPN
- ClinicalTrials.gov ID
- NCT06186479
- Acronym / sponsor ID
- kp-acs-2
- Conditions
- Chemotherapy-induced Polyneuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- WALA Heilmittel GmbHUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: Aconite pain oil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aconite pain oilParticipants 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. | Drug | Verum |
| PlaceboParticipants 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. | Drug | Placebo |
Primary outcome
Percentage of CIPN 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Equipment and Supplies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aconite pain oil in people with Chemotherapy-induced Polyneuropathy, run by WALA Heilmittel GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Stintzing, Prof. Dr. (0497164930-0, klin-pruef-klifo@wala.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of CIPN 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.