Study on Lacosamide and Duloxetine for Patients with Chemotherapy-Induced Neuropathic Pain

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What is this study about?

This clinical trial is focused on studying the effects of two medications, lacosamide and duloxetine, in patients experiencing pain due to chemotherapy-induced neuropathy. Chemotherapy-induced neuropathy is a type of nerve damage that can occur after chemotherapy treatment, leading to pain and discomfort. The purpose of the study is to compare the pain-relieving effects of lacosamide, which is taken as film-coated tablets, and duloxetine, which is taken as hard gastro-resistant capsules.

Participants in the study will be randomly assigned to receive either lacosamide or duloxetine. The study will last for a period of eight weeks, during which the effectiveness of the medications in reducing pain will be observed. Participants will take the medication orally, and their pain levels will be monitored throughout the study. The study aims to determine if lacosamide is as effective as duloxetine in managing pain caused by chemotherapy-induced neuropathy.

In addition to assessing pain relief, the study will also evaluate patient satisfaction with the treatment and any side effects experienced. This information will help in understanding the overall benefits and potential drawbacks of each medication for individuals suffering from chemotherapy-induced neuropathy. The findings from this study could provide valuable insights into better pain management strategies for patients who have undergone chemotherapy.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age over 18, ability to provide consent, and a history of chemotherapy-induced neuropathic pain.

Participants must have a pain score of 4 or higher and symptoms persisting at least 3 months after chemotherapy.

2 randomization

Participants are randomly assigned to receive either lacosamide or duloxetine to compare their effectiveness in managing pain.

3 medication administration

Participants receiving lacosamide will take Vimpat 50 mg film-coated tablets orally.

Participants receiving duloxetine will take Cymbalta 30 mg hard gastro-resistant capsules orally.

4 treatment duration

The treatment continues for a specified period, during which the effectiveness of the medication is monitored.

5 evaluation of pain intensity

The primary focus is on the pain intensity score during the last 4 weeks of treatment.

6 assessment of secondary outcomes

Secondary outcomes include evaluating patient satisfaction with the treatment and monitoring any side effects experienced.

7 completion of the study

The study is estimated to conclude by December 31, 2025, after which the collected data will be analyzed.

Who Can Join the Study?

Must be older than 18 years.
Must be able to give both oral and written permission to participate.
Must show signs of neuropathy, which means nerve damage, through special tests that measure how you feel things compared to healthy people.
Must have a pain score of 4 or higher. This means your pain level is measured on a scale, and it needs to be at least 4.
Must have had chemotherapy with specific drugs like taxanes, platinums, vicalkiniods, or bortezomib in the past.
Must have symptoms of neuropathic pain, which is pain caused by nerve damage, for at least 3 months after finishing chemotherapy.

Who Cannot Join the Study?

Patients who are currently receiving other treatments for their neuropathic pain. Neuropathic pain is a type of pain caused by damage to the nerves.
Patients with a history of allergic reactions to the medications being tested. An allergic reaction is when your body reacts badly to something, causing symptoms like a rash or difficulty breathing.
Patients with severe liver or kidney problems. The liver and kidneys are important organs that help clean your blood and remove waste from your body.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial recently. This is to avoid any interference with the results of the study.
Patients with certain mental health conditions that might affect their ability to participate in the study. Mental health conditions are illnesses that affect your mood, thinking, and behavior.
Patients who are unable to follow the study procedures. This means they might have difficulty understanding or remembering what they need to do during the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Lhglo Uytctvsszxqy Mygiyxn Coxkrze (ygajw	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	11.01.2021

Trial locations

Investigated drugs:

Lacosamide is a medication being studied for its ability to relieve pain in patients who have developed nerve pain as a result of chemotherapy. It is being compared to another medication to see if it is equally effective in reducing pain symptoms.

Duloxetine is a medication commonly used to treat nerve pain and depression. In this trial, it is being used as a comparison to evaluate the effectiveness of another medication in treating pain caused by chemotherapy.

Investigated diseases:

Chemotherapy-Induced Neuropathic Pain – This condition occurs as a side effect of certain chemotherapy drugs used in cancer treatment. It is characterized by nerve damage that leads to pain, tingling, or numbness, primarily in the hands and feet. The pain can be persistent and may vary in intensity, often described as burning or shooting. As the condition progresses, it can interfere with daily activities and reduce the quality of life. The symptoms may begin during chemotherapy and can continue even after treatment has ended. The severity and duration of the pain can differ from person to person.

Trial ID:

2024-511008-17-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Lacosamide and Duloxetine for Patients with Chemotherapy-Induced Neuropathic Pain

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