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Compares treatment options for Chemotherapy-induced Peripheral Neuropathy
Official title Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT05840562
What this study is testing
What is Capsaicin?
Capsaicin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Also referred to as Qutenza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Caen, France
- Grenoble, France
- Limoges, France
- Lyon, France
- Nantes, France
- Nice, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Caen, France; Grenoble, France; Limoges, France; Lyon, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.