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Can a herbal oil shield cancer patients from chemo nerve pain?

NCT ID NCT06186479

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study tests whether a topical oil made from aconite can prevent or reduce nerve damage (polyneuropathy) caused by chemotherapy in cancer patients. About 350 adults with solid tumors receiving taxane or platinum chemotherapy will apply the oil or a placebo to their skin twice daily. The goal is to see if the oil lowers the chance of developing moderate-to-severe nerve symptoms and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aconite pain oil
What this could lead to
If it works, this could offer a simple, topical way to prevent or ease nerve pain caused by chemotherapy, helping patients maintain a better quality of life during cancer treatment.
What could go wrong
This is a phase 3 trial, but it is still testing a natural oil against a placebo. The effect may be small or no better than placebo, and individual results may vary. Aconite can be toxic if misused, though topical use is generally safer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A consent form, fully dated and signed by the patient and the principal investigator/investigator, is available 2. Patients with a minimum age of 18 years 3. Patients with a Karnofsky Index ≥ 70% 4. Patients with an assumed life expectancy of at least 12 months 5. Patients with solid tumours 6. 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) 7. Patients of childbearing age must provide a negative pregnancy test Exclusion Criteria: 1. Participation in an interventional trial (with an investigational product) that is concurrent or occurred within 4 weeks prior to inclusion in this trial 2. Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index \< 1) 3. 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 4. Patients with known hypersensitivity to camphor and/or any of the other ingredients of Aconite Pain Oil, as well as peanut or soy 5. 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 6. Patients with a planned application of chemotherapy at ≥4-week intervals 7. Patients with alcohol/drug/medication dependency 8. Patients with known genetic predispositions to polyneuropathies 9. Patients with previous or current polyneuropathy irrespective of cause 10. 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 11. 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 12. Patients with active and/or clinically relevant infectious diseases: HIV, Lyme disease, hepatitis B/C, herpes infections 13. Known presence of multiple myeloma or non-Hodgkin's lymphoma 14. 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 15. Patients with metastases in the central nervous system 16. History of amputation of extremities 17. Patients with distal muscle weakness and/or atrophy 18. 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) 19. 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 20. 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 21. Planned acupuncture for the treatment of CIPN during the trial 22. 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 23. Electrotherapy on the extremities up to 1 week before the start of the trial (baseline) and during the trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medizinische Fakultät Mannheim der Uniklinik Heidelberg

    RECRUITING

    Mannheim, 68167, Germany

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