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

Overview

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.

Interventions

• Drug Aconite pain oil
  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.
• Drug 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.

Primary outcome measures

• 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]
• 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 criteria

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 (3 lunar months / 12 weeks)
• 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Germany · 1 center

• Medizinische Fakultät Mannheim der Uniklinik Heidelberg — Mannheim

Identifiers

NCT: NCT06186479 · kp-acs-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗