Capsaicin patch compared to oral duloxetine for chemotherapy-induced nerve pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a capsaicin patch versus oral duloxetine in treating chemotherapy-induced peripheral neuropathy (CIPN), a painful condition affecting many cancer patients after neurotoxic chemotherapy. Participants will be patients experiencing painful symptoms such as numbness and tingling in a 'gloves and socks' distribution, with a pain score of 4 or higher. The study aims to determine which treatment provides better relief from CIPN symptoms, with a focus on those whose symptoms persist after chemotherapy. The trial is designed as a phase 3 interventional study to provide robust data on treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut de Cancérologie de l'Ouest
  Angers, France Recruiting
• CHU Bordeaux
  Bordeaux, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• CHU Grenoble
  Grenoble, France Recruiting
• Polyclinique Chenieux
  Limoges, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting

Study contacts

• Study coordinator: François Xavier PILOQUET, MD
• Email: francois-xavier@piloquet@ico.unicancer.fr
• Phone: +33 2 40 67 99 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling

  This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.

  Recruiting at 3 sites Azienda Sanitaria dell'Alto Adige · Bolzano, Bolzano and 3 other locations · NCT07780955

• SIR2501 plus Paclitaxel for solid tumors

  This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.

  Recruiting at 3 sites Phase 2 Sironax USA, Inc. · Hollywood, Florida and 4 other locations · NCT07765446

• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

  This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07673614

• Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy

  Researchers are testing a small, at-home device that you wear on the ear to see if it eases nerve pain from chemotherapy.

  Recruiting University of Miami · Coral Gables, Florida · NCT07596030

• Blood extracellular vesicles to detect chemotherapy-related nerve damage.

  We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07558447

• Virtual LASO-3 diet program to ease chemotherapy-related numbness and tingling

  This trial tests whether a virtual diet program that lowers added sugar and increases fiber and omega-3s can help cancer survivors who have numbness, tingling, or pain after neurotoxic chemotherapy.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07365007

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.