Use of Aconit Pain Relief Oil to Prevent Grade II Chemotherapy-Induced Polyneuropathy (CIPN) and to Alleviate the Symptoms of Existing CIPN in Cancer Patients

Chemotherapy-induced polyneuropathy (CIPN) is a common and debilitating side effect of chemotherapy in which multiple nerves—particularly peripheral nerves—are damaged simultaneously. Drugs in the taxane and platinum-based classes are known to cause this side effect. CIPN typically manifests as tingling, numbness, or a burning sensation in the hands and feet. In addition, stabbing, electric-shock-like pain, sensory disturbances (e.g., impaired temperature sensation), muscle weakness, and coordination problems may occur. CIPN can be classified into different severity levels based on the extent of the symptoms and the impact on daily life. Grade II, for example, refers to a mild impairment of daily activities due to noticeable tingling, numbness, or pain. CIPN can significantly impair patients’ quality of life and may even lead to the discontinuation of chemotherapy. To date, there is no clearly effective treatment that can prevent the development of CIPN. Currently, symptoms can be alleviated through pain medication, physical therapy, and the application of a capsaicin cream.

The goal of the present Phase-3b study is to investigate the efficacy of Aconit Pain Oil in preventing chemotherapy-induced polyneuropathy, alleviating symptoms typical of CIPN, and improving quality of life in oncology patients undergoing chemotherapy. As part of the study, patients will be randomly assigned to two groups. Group 1 will receive treatments as part of routine care using Aconit pain relief oil, and Group 2 will receive a placebo (peanut oil). Regular examinations will be conducted to assess the patients’ nerve function and quality of life. The study is blinded, meaning the patients do not know which oil is being used. Treatments and follow-up examinations as part of the study are expected to continue through August 2027, during which the effectiveness of the oil treatment will be evaluated. The key question is whether the risk of Grade II CIPN can be reduced and existing CIPN symptoms alleviated.

Women and men aged 18 and older with a solid tumor who are scheduled to undergo at least 3 months of chemotherapy with taxanes or platinum derivatives—or a combination of both—are eligible to participate.