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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany
Universitätsklinikum Freiburg	Freiburg Im Breisgau	Germany

Other Sites

Site Name	City	Country
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Muehlenkreiskliniken AöR	Minden	Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH	Ludwigsburg	Germany
Klinikum Osnabrück GmbH	Osnabrück	Germany
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts	Mutlangen	Germany
Hautklinik, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität	Nürnberg	Germany
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU	Deggendorf	Germany
Marien-Hospital Wesel gGmbH	Wesel	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Heidelberg University	Mannheim	Germany
Pi.Tri Studien GmbH	Offenburg	Germany
Gynäkologische Praxisklinik Hamburg-Harburg	Hamburg	Germany
Agaplesion Frankfurter Diakonie Kliniken gGmbH	Frankfurt	Germany
Agaplesion Diakonieklinikum Rotenburg gGmbH	Rotenburg	Germany
Ualocyavuewsmttvagquc Aojiapez	Augsburg	Germany
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Kvzkrfwddfl Shr Envrsmjvm Uui Sdu Bvhpnha Hhahi (bhlomc Gwxq	Halle (Saale)	Germany
Kjmaiu Dgr Hywmkwv Gdtd	Stade	Germany
Mcapozelyv Oqxfocgyx Pduymc	Mannheim	Germany
Spn Brywkvdw Kokpsnniyxt Glkl	Hildesheim	Germany
Kuemuggv dbr Ucxprxwacrvc Mxgdmppk Apf	Munich	Germany
Uearqiidioewnyfducxm Raairmietmxmrplccj	Neuruppin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.01.2024

Trial locations

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.

Investigated diseases:

Polyneuropathy

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.

Trial ID:

2022-502889-24-00

Protocol code:

kp-acs-2

Trial Phase:

Therapeutic confirmatory (Phase III)

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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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