## Protocol Section
### Identification Module
**NCT ID:** NCT06186479

**Brief 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

**Official Title:** 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

#### Organization Study ID Info
**ID:** kp-acs-2
#### Organization
**Class:** OTHER
**Full Name:** WALA Heilmittel GmbH
### Status Module
#### Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-09

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-13

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-01-02
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-27
**Study First Submit QC Date:** 2023-12-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** WALA Heilmittel GmbH

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Chemotherapy-induced Polyneuropathy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 350

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Aconite pain oil

**Label:** Verum

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Verum

**Description:** 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.

**Name:** Aconite pain oil

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** 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.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** for neuralgia, paraesthesia, peripheral motor polyneuropathy, peripheral sensory polyneuropathy

**Measure:** 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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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 (start of chemotherapy within the next 10 days)
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 use of neurotoxic medication (e.g., taxanes, platinum derivatives, metronidazole, isoniazid, amiodarone, vinca alkaloids, checkpoint inhibitors)
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

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** klin-pruef-klifo@wala.de

**Name:** Florian Stintzing, Prof. Dr.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mannheim

**Contacts:**

***Contact 1:***

- **Name:** R.-D. Hofheinz, Prof. Dr.

- **Role:** CONTACT

**Country:** Germany

**Facility:** Medizinische Fakultät Mannheim der Uniklinik Heidelberg

**Status:** RECRUITING

**Zip:** 68167

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13999

- Name: Polyneuropathies

- Relevance: HIGH

- As Found: Polyneuropathy

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000011115

- Term: Polyneuropathies

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T48

- Name: Aconite

- Relevance: HIGH

- As Found: Agrylin®

### Misc Info Module

- Version Holder: 2024-05-24
