Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT05840562

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2027-03-31

Brief Summary

Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin.

This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness, tingling, and less frequently shooting/burning pain. These symptoms spread proximally to affect both lower and upper extremities in a characteristic "stocking and glove" distribution.

Many symptoms of CIPN may resolve completely for some patients. However, CIPN is only partly reversible for most. In the worst instances, it does not appear to be reversible at all and can even increase over time.

CIPN is difficult to manage. Only duloxetine is recommended, based on the positive result of a randomized phase III double-blind placebo-controlled crossover trial. The use of duloxetine resulted in a greater reduction in pain and was effective in decreasing numbness and tingling in the feet. But, systemic antidepressants are often associated with toxicities and patients often refuse or abandon the treatment.

Capsaicin inhibits neural transmission in sensory axons and has been proven as effective on the intensity of pain for post-herpetic neuralgia and human immunodeficiency virus-associated neuropathy. Efficacy appears at one month and persists for at least 2 months.

Only a few studies focused on the efficacy of capsaicin 179 mg patch on the intensity of CIPN-induced pain. These non-randomized studies show that more than 50% of patients have a reduction in pain intensity of more than 30%.

Until now, no clinical trial has compared the efficacy of the capsaicin 179 mg patch with duloxetine.

Accordingly, this open-label phase 3, randomized, multicenter trial, will compare efficacy and safety of capsaicin patch with oral duloxetine on painful CIPN persisting more than 3 months after the end of the responsible chemotherapy.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

The capsaicin 179 mg patch should be applied to the most painful extremities.

Application:

• Capsaicin patches must be applied to intact, dry and non-irritated skin and allowed to remain in place for 30 minutes for the feet and maximum 60 minutes for hands depending on immediate tolerance.
• If all the areas to be treated cannot be treated in once, a second session will be organised between 3 and 7 days later. Further sessions can be held within 15 days of the 1st session (up to 4 sessions in total). All sessions will be considered as one application.
• 1 application may require several treatment sessions.
• The patch, which may be cut to shape, was used within 2 h of opening the foil pouch.

After the first treatment session, treatment may be repeated every 2 months (at weeks 9, 17, 25) as warranted by the persistence or return of pain.

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

Application of capsaicin patches 179 mg

Control Arm

Duloxetine should be initiated at an initial dose of 30 mg orally for 1 week followed by a maintenance dose of 60 mg per day, given either once a day or 30 mg orally 2 times a day.

After W6, in case of insufficient response to the 60 mg dose, the dosage may be increased to the maximum dose of 120 mg.

Group Type: ACTIVE_COMPARATOR

Duloxetine

Intervention Type: DRUG

Administration of duloxetine

Interventions

Capsaicin

Application of capsaicin patches 179 mg

Intervention Type: DRUG

Duloxetine

Administration of duloxetine

Intervention Type: DRUG

Other Intervention Names

Qutenza; Cymbalta

Eligibility Criteria

Inclusion Criteria

• Patient with CIPN manifested by painful symptoms such as numbness and / or tingling and / or burning pain in fingers / hands and toes / feet with a typical distribution in "gloves and socks" beginning after neurotoxic chemotherapy
• Painful CIPN as expressed by the BPI-SF (average pain) as ≥ 4/10
• CIPN persisting at least 1 month after completion of chemotherapy with taxanes and/or platinum salts and sensory CIPN grade ≥ 2 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE v.5.0) grading scale
• Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs)
• Healthy and non-irritated skin on the areas to be treated
• Absence of neurotoxic chemotherapy planned during the next 6 months after inclusion
• Patient affiliated to a social security scheme
• > 18 years old
• Signed written informed consent form

Exclusion Criteria

• Presence of known carcinomatous meningitis
• Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)
• Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)
• Patient already treated for this neuropathy with Capsaicin patches
• Patient treated by antidepressant drugs at time of inclusion
• Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
• Patients with known severe renal or hepatic failure
• Breastfeeding or pregnant women
• Persons deprived of liberty or guardianship (including curatorship)
• Patient unable to undergo regular medical follow-up for geographical, social or psychological.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: collaborator

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Xavier PILOQUET, MD

Role: STUDY_DIRECTOR

Institut de Cancérologie de l'Ouest

Locations

Institut de Cancérologie de l'Ouest

Angers, , France

Site Status: RECRUITING

CHU Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Centre François Baclesse

Caen, , France

Site Status: RECRUITING

CHU Grenoble

Grenoble, , France

Site Status: RECRUITING

Polyclinique Chenieux

Limoges, , France

Site Status: RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

"L'Hôpital Privé du Confluent "

Nantes, , France

Site Status: RECRUITING

Centre Antoine Lacassagne

Nice, , France

Site Status: RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, , France

Site Status: RECRUITING

Institut de Cancérologie Strasbourg Europe

Strasbourg, , France

Site Status: RECRUITING

Institut Claudius Regaud -IUCT-O

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François Xavier PILOQUET, MD

Role: CONTACT

francois-xavier@piloquet@ico.unicancer.fr

+33 2 40 67 99 00

Marine TIGREAT

Role: CONTACT

marine.tigreat@ico.unicancer.fr

Facility Contacts

Marine Tigreat

Role: primary

marine.tigreat@ico.unicancer.fr

Fanny LAFAYE, MD

Role: primary

fanny.lafaye@chu-bordeaux.fr

Frédérique Bisiaux, MD

Role: primary

f.bisiaux@baclesse.unicancer.fr

Caroline MAINDET, MD

Role: primary

Gaelle Martine Fabre, MD

Role: primary

g.martine@polyclinique-limoges.fr

Olivier RENARD, MD

Role: primary

olivier.renard@lyon.unicancer.fr

Thomas CUVIER, MD

Role: primary

Anne FOGLIARINI, MD

Role: primary

Marine Tigreat

Role: primary

marine.tigreat@ico.unicancer.fr

Anna SCHOHN, MD

Role: primary

a.schohn@icans.eu

Antoine BODEN, MD

Role: primary

boden.antoine@iuct-oncopole.fr

Other Identifiers

ICO-2022-02

Identifier Type: -

Identifier Source: org_study_id