Capsaicin 179 mg patch versus oral Duloxetine in patients with chemotherapy-induced peripheral neuropathy: a phase 3 randomized multicentric open-label study (CAPNEUCHIM)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut De Cancerologie De L Ouest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

20 Oct 2023 → ongoing

Decision date (initial)

2023-08-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

GRUNENTHAL · DGOS Inca PHRC K 2021 (PHRCK21-061)

External identifiers

EU CT number

2023-504618-31-00

ClinicalTrials.gov

NCT05840562

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate that capsaicin 179 mg patch once compared to duloxetine daily, improves painful CIPN after a 5-week treatment period

Secondary objectives 8

1. a) To assess safety
2. b) To evaluate the efficacy on non-painful sensory symptoms
3. c) To assess the improvement in quality of life : QLQ C30 + SF12
4. d) To assess Interference with Daily Function
5. e) To assess the global improvement of CIPN
6. f) To assess the global satisfaction : PGIC
7. g) To evaluate the efficacy and the safety of repeated application of capsaicin 179 mg patch
8. h) To measure the psychometric properties of the QLQ CIPN20 French version

Conditions and MedDRA coding

Chemotherapy induced peripheral neuropathy (CIPN)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. 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
2. 2. Painful CIPN as expressed by the BPI-SF as ≥ 4/10
3. 3. 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
4. 4. Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs, topic treatment)
5. 5. Healthy and non-irritated skin on the areas to be treated
6. 6. Absence of neurotoxic chemotherapy planned during the next 6 months after inclusion
7. 7. Patient affiliated to a social security scheme
8. 8. ≥ 18 years old
9. 9. Signed written informed consent form
10. 10. Patient consent to use contraception during treatment

Exclusion criteria 12

1. 1. Presence of known carcinomatous meningitis
2. 10. Patient unable to undergo regular medical follow-up for geographical, social or psychological
3. 11. Patient already treated by photo biomodulation at time of inclusion
4. 2. Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)
5. 3. Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)
6. 4. Patient already treated for this neuropathy with Capsaicin patches
7. 5. Patient treated by antidepressant drugs belonging to the SSRI or SNRI within 30 days of prior to inclusion Exception: Patients receiving mirtazapine or mianserin may be included provided that: the dose has been stable for at least 4 weeks before inclusion
8. 6. Known 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)
9. 7. Patients with known severe renal or hepatic failure
10. 8. Breastfeeding or pregnant women
11. 9. Persons deprived of liberty or guardianship (including curatorship)
12. 12. Patient treated by botulinum toxin A in subcutaneous within 30 days of inclusion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of painful CIPN patients experiencing a 30% improvement in their average pain severity score at 6 weeks compared to baseline (measured on day 1 of week 6)

Secondary endpoints 8

1. a) Safety will be assessed according to the CTC-AE v5.0, at week 6, week 12, week 19 and week 26
2. b) Efficacy on non-painful sensory symptoms (tingling, numbness) will be assessed by the rate of patients improving by at last 30% their sensory scale scores from the quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20 and NPSI), between baseline and week 6, week 12, week 19 and week26
3. c) Quality of life will be assessed by QLQ C30 and the SF (short form)-12 quality of life scale at baseline, week 6, week 12, week 19 and week 26. SF 12 is an abbreviated version of SF-36, a generic Health Related Quality of Life (HRQoL) questionnaire
4. d) Functional interference will be assessed using the Brief Pain Inventory-Short Form (BPI-SF) at baseline, week 6, week 12, week 19 and week 26
5. e) Global improvement of CIPN will be assessed by the total score of the EORTC QLQ-CIPN20 at baseline, week 6, week 12, week 19 and week 26
6. f) Global satisfaction of the patient will be assessed by the Patient Global Impression of Change (PGIC) reflecting patient's belief about treatment efficacy (evaluated at week 6, week 12, week 19 and week 26)
7. g) Demonstration of improved efficacy and safety after repeat, applications of capsaicin will be assessed by paired comparison of the different scores between baseline, week 6, week 12, week 19 and week 26
8. h) The psychometric properties will be assessed from the French-CIPN20 - at baseline in all patients for structural validity and known-group comparisons for structural validity - at inclusion and at W0 (patch application) in patients randomised in the experimental arm for reliability

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut De Cancerologie De L Ouest

Sponsor organisation

Institut De Cancerologie De L Ouest

Address

15 Rue Andre Boquel

City

Angers

Postcode

49100

Country

France

Scientific contact point

Organisation

Institut De Cancerologie De L Ouest

Contact name

Marine TIGREAT

Public contact point

Organisation

Institut De Cancerologie De L Ouest

Contact name

Marine TIGREAT

Locations

1 EU/EEA country · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications