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Study on Aconite Pain Oil to Prevent and Reduce Symptoms of Chemotherapy-Induced Polyneuropathy in Cancer Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as chemotherapy-induced polyneuropathy (CIPN), which can occur in patients undergoing cancer treatment. The trial aims to explore the effectiveness of a treatment called Aconit Schmerzöl, also known as Aconite Pain Oil, in preventing and reducing the symptoms of CIPN. This condition can cause nerve damage, leading to symptoms like pain, tingling, and numbness, which can affect the quality of life. The study will compare the effects of Aconit Schmerzöl with a placebo to see if it can help reduce the risk of developing CIPN and improve the overall well-being of patients.

Participants in the study will be patients who are receiving chemotherapy treatments that include medications such as Taxanes and Carboplatin. These medications are commonly used in cancer treatment but can sometimes lead to CIPN. The trial will involve the use of Aconit Schmerzöl, which is applied externally, and aims to see if it can help prevent or lessen the severity of CIPN symptoms. The study will take place over a period of time, with regular assessments to monitor the effects of the treatment on the participants' symptoms and quality of life.

The purpose of this study is to determine if Aconit Schmerzöl can effectively reduce the risk of CIPN and improve the quality of life for patients undergoing chemotherapy. By participating in this trial, researchers hope to gather valuable information that could lead to better management of CIPN symptoms in the future. The study will involve regular check-ups and assessments to track the progress and any changes in the participants' condition, ensuring a comprehensive understanding of the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, a consent form must be fully dated and signed by both the patient and the principal investigator.
Eligibility criteria include being at least 18 years old, having a Karnofsky Index of 70% or higher, and an expected life expectancy of at least 12 months.
Patients must have solid tumors and be scheduled to receive chemotherapy with taxanes or platinum derivatives for at least 3 months.
Step 2
Treatment initiation
The treatment involves the use of Aconite Pain Oil, which is applied topically to prevent and reduce symptoms of chemotherapy-induced polyneuropathy (CIPN).
The oil is used externally, and the application is part of the routine care during chemotherapy.
Step 3
Monitoring and assessment
Throughout the trial, the occurrence and severity of CIPN are monitored. The primary goal is to reduce the risk of CIPN grade II or higher by 35% compared to a placebo.
Secondary assessments include monitoring the time to occurrence of CIPN grade III, regression of CIPN symptoms, and various sensory and motor functions over time.
Step 4
Ongoing evaluation
Regular evaluations are conducted to assess thermoception, tactile perception, nociception, and other sensory responses.
Motor skills, reflexes, and patient satisfaction are also evaluated periodically to track changes and improvements.
Step 5
Completion of treatment
The trial is expected to continue until August 31, 2027, with ongoing assessments and data collection.
Upon completion, the effects of the treatment on CIPN and overall quality of life will be analyzed and documented.

Who can join the trial?

7 criteria

A consent form, fully dated and signed by the patient and the principal investigator/investigator, is available.
Patients must be at least 18 years old.
Patients must have a Karnofsky Index of 70% or higher. The Karnofsky Index is a way to measure a patient's ability to perform everyday activities. A score of 70% means the patient can care for themselves but may not be able to do normal activities or work.
Patients must have an expected life span of at least 12 months.
Patients must have solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas.
Patients must be scheduled to receive unmodified chemotherapy with taxanes or platinum derivatives or their combination, which are types of cancer treatment drugs, for at least 3 months (3 lunar months / 12 weeks).
Patients of childbearing age must provide a negative pregnancy test.

Who cannot join the trial?

6 criteria

Patients who are currently receiving or have received other treatments that might interfere with the study.
Patients with a history of severe allergic reactions to any of the study medications.
Patients with other serious health conditions that could affect their safety or the study results.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently.

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Verified sites

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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Responsive
Stuttgart, Germany
Klinikum der Universitaet Muenchen AöR
Verified
Munich, Germany

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Investigated drugs

Aconite Pain Oil is being tested in this clinical trial to see if it can help prevent or reduce the symptoms of nerve damage caused by chemotherapy, known as chemotherapy-induced polyneuropathy (CIPN). The goal is to see if this oil can lower the risk of developing more severe nerve damage and improve the quality of life for patients undergoing chemotherapy.

What is already known about the treatment

Aconite Pain Oil – Aconite Pain Oil is administered topically, meaning it is applied directly to the skin. It is currently being studied in clinical trials to assess its effectiveness in preventing and reducing symptoms of chemotherapy-induced polyneuropathy (CIPN) in cancer patients. The main therapeutic indication is to alleviate nerve pain and improve the quality of life for patients undergoing chemotherapy. At the molecular level, it is believed to work by modulating nerve signals and reducing inflammation, although the exact mechanism is still under investigation. It is classified as a topical analgesic in pharmacology.

Investigated diseases

Chemotherapy-Induced Polyneuropathy (CIPN) – This condition occurs as a side effect of certain chemotherapy drugs used in cancer treatment. It involves damage to the peripheral nerves, which can lead to symptoms such as numbness, tingling, and pain, primarily in the hands and feet. As the condition progresses, individuals may experience difficulties with balance and coordination, as well as muscle weakness. The severity of symptoms can vary, and they may worsen with continued chemotherapy. In some cases, symptoms may persist even after the cessation of chemotherapy. The progression and impact of CIPN can significantly affect a patient's quality of life.