Study Comparing Capsaicin Patch and Duloxetine for Patients with Chemotherapy-Induced Peripheral Neuropathy

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What is this study about?

This clinical trial is focused on studying a condition known as Chemotherapy-Induced Peripheral Neuropathy (CIPN). This condition often occurs after chemotherapy treatment and can cause painful symptoms such as numbness, tingling, or burning pain in the fingers, hands, toes, and feet. The study aims to compare the effectiveness of two treatments: a Capsaicin patch and an oral medication called Duloxetine. Capsaicin is a substance found in chili peppers and is used in a patch form applied to the skin, while Duloxetine is taken as a capsule by mouth.

The purpose of the study is to determine if the Capsaicin patch can improve painful symptoms of CIPN more effectively than Duloxetine after a 5-week treatment period. Participants in the study will be randomly assigned to receive either the Capsaicin patch or Duloxetine. The study will last for several weeks, during which participants will receive their assigned treatment and be monitored for changes in their symptoms.

Throughout the study, participants will have regular check-ins to assess their pain levels and any changes in their quality of life. The study will also evaluate the safety of the treatments and their impact on non-painful symptoms like tingling and numbness. The goal is to find a treatment that provides significant relief from the painful symptoms associated with CIPN and improves the overall well-being of those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes evaluating the presence of chemotherapy-induced peripheral neuropathy (CIPN) with symptoms such as numbness, tingling, or burning pain in the fingers, hands, toes, or feet.

The severity of pain will be measured using a scale where a score of 4 out of 10 or higher is required. The condition must have persisted for at least one month after completing chemotherapy with specific drugs.

2 randomization

Participants will be randomly assigned to one of two treatment groups: one receiving a capsaicin 179 mg patch and the other receiving oral duloxetine.

3 treatment administration

For those in the capsaicin patch group, the patch will be applied once during the study period.

Participants in the duloxetine group will take the medication orally every day for a duration of 5 weeks.

4 follow-up assessments

At week 6, the primary endpoint will be evaluated by measuring the percentage of participants experiencing a 30% improvement in their average pain severity score compared to the start of the study.

Secondary assessments will occur at weeks 6, 12, 19, and 26, focusing on safety, efficacy on non-painful symptoms, quality of life, functional interference, global improvement of CIPN, and patient satisfaction.

5 completion of study

The study is expected to conclude by June 30, 2027. Participants will have contributed valuable data to assess the effectiveness and safety of the treatments for painful CIPN.

Who Can Join the Study?

Patient with CIPN (Chemotherapy Induced Peripheral Neuropathy) showing painful symptoms like numbness, tingling, or burning pain in fingers, hands, toes, or feet, in a pattern like “gloves and socks” that started after chemotherapy.
Painful CIPN with a pain score of 4 out of 10 or higher on a pain scale.
CIPN that has lasted at least 1 month after finishing chemotherapy with specific drugs called taxanes or platinum salts, and a sensory CIPN severity of grade 2 or higher according to a standard grading scale for side effects.
Stable doses of other medications for nerve pain, like antiepileptic drugs or topical treatments, for at least 4 weeks before joining the study.
Healthy and non-irritated skin in the areas that will be treated.
No planned neurotoxic chemotherapy (chemotherapy that can damage nerves) in the next 6 months after joining the study.
Patient must be part of a social security scheme.
Patient must be 18 years old or older.
Patient must sign a written informed consent form, agreeing to participate in the study.

Who Cannot Join the Study?

Patients who have a different type of nerve pain not caused by chemotherapy cannot participate.
Patients who are currently using other treatments for nerve pain that might interfere with the study cannot participate.
Patients with severe skin conditions that could affect the application of the patch cannot participate.
Patients who have had a recent heart attack or have severe heart problems cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with a history of severe allergic reactions to capsaicin or similar substances cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Comite Entreprise Paul Papin	Angers	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Polyclinique De Limoges	Limoges	France
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier De Cholet	Cholet	France
Clinique Victor Hugo	Le Mans	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Centre Francois Baclesse	Caen	France
L’Hopital Prive Du Confluent	Nantes	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Institut De Cancerologie De L Ouest	Saint-Herblain	France
Centre Hospitalier Saint Nazaire	St Nazaire	France
Psehdoafkipq Slzgz Ginrzb	Nice	France
Ctxxgd Hfiqmttosdf Do Sxdyawbxyebt	Saint-Brieuc	France
Cazzmn Ldpn Bodxyt	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.10.2023

Trial locations

Investigated drugs:

Capsaicin Patch is a treatment used in this clinical trial. It is a patch that you apply to your skin. The patch contains capsaicin, which is a natural compound found in chili peppers. When applied, it helps to relieve pain by reducing the amount of a substance in the body that sends pain signals to the brain. In this trial, the capsaicin patch is being tested to see if it can help reduce pain caused by nerve damage from chemotherapy.

Duloxetine is a medication taken by mouth, usually in the form of a pill. It is commonly used to treat depression and anxiety, but it also helps relieve nerve pain. In this trial, duloxetine is being used to see if it can help reduce the pain experienced by patients who have nerve damage from chemotherapy. The study is comparing the effectiveness of duloxetine with the capsaicin patch to see which one works better for this type of pain.

Investigated diseases:

Neuropathy peripheral

Chemotherapy-induced peripheral neuropathy (CIPN) – This condition occurs as a side effect of certain chemotherapy drugs, affecting the peripheral nerves. It typically presents as pain, tingling, numbness, or weakness in the hands and feet. The symptoms arise due to damage to the nerves outside the brain and spinal cord. As the condition progresses, it can lead to difficulties in performing daily activities due to sensory and motor impairments. The severity of symptoms can vary, and they may persist even after the cessation of chemotherapy. Over time, the symptoms may stabilize or improve, but in some cases, they can become chronic.

Trial ID:

2023-504618-31-00

Protocol code:

ICO-2022-02

NCT ID:

NCT05840562

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Capsaicin Patch and Duloxetine for Patients with Chemotherapy-Induced Peripheral Neuropathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?