Efficacity of a Standardized Hypnotic Message During the Application of a Qutenza (Capsaicin) 8% Patch (ENHYZA)

Institut de Cancérologie de Lorraine

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Other: music therapy; Other: hypnotic message; Drug: QUTENZA®

Study type: Interventional

Funder types: Other

Identifiers

NCT02822625

2016-A00234-47

Details and patient eligibility

About

QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. Acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this hypothesis.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who have already received at least a QUTENZA® patch
• Treatment for patient in failure to conventional treatments for neuropathic pain other than diabetics
• Age >18 years
• Eastern Cooperative Oncology Group (ECOG) performance status <3
• Patient must be affiliated to a social security system
• Ability to provide written informed consent
• Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

Exclusion criteria

• Patient with psychotic disorders
• Patient with hearing disorders
• Patient not understanding the French language
• Age < 18 years
• Patient requiring analgesic premedication before applying the patch QUTENZA®
• Patient with a history of hypersensitivity to capsaicin or any of the excipients of the patch
• Patient deprived of liberty or under supervision

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups, including a placebo group

arm 1

Experimental group

Description:

Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care.

Treatment:

Drug: QUTENZA®

arm 2

Active Comparator group

Description:

Patients, followed in the institut and for whom a new application of QUTENZA® is required. Patients will receive QUTENZA® according to standard procedure with a standardized hypnotic message

Treatment:

Other: hypnotic message

Drug: QUTENZA®

arm 3

Placebo Comparator group

Description:

Patients, followed in the institut and for whom a new application of QUTENZA® is required. Patients will receive QUTENZA® according to standard procedure with a music therapy

Treatment:

Other: music therapy

Drug: QUTENZA®