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

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Completed

CT.gov ID

NCT02822625

Collaborator

(none)

Enrollment

Location

Arms

34.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: QUTENZA® Other: hypnotic message Other: music therapy	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Efficacity of a Standardized Hypnotic Message on Pain Experienced During the Application of a Qutenza (Capsaicin) 8% Patch in Patients With Peripheral Neuropathic Pain

Actual Study Start Date :

Aug 30, 2016

Actual Primary Completion Date :

Jul 10, 2019

Actual Study Completion Date :

Jul 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: arm 1 Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care.	Drug: QUTENZA®
Active Comparator: arm 2 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	Drug: QUTENZA® Other: hypnotic message
Placebo Comparator: arm 3 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	Drug: QUTENZA® Other: music therapy

Arm

Intervention/Treatment

Experimental: arm 1

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

Drug: QUTENZA®

Active Comparator: arm 2

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

Drug: QUTENZA®

Other: hypnotic message

Placebo Comparator: arm 3

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

Drug: QUTENZA®

Other: music therapy

Outcome Measures

Primary Outcome Measures

Compare pain induced by patch QUTENZA® [1 day]
Pain will be evaluated by a numerical scale before, just after, and after installation of the patch

Secondary Outcome Measures

Compare anxiety induced by patch QUTENZA® [1 day]
Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch
Compare the real time of application of the patch [1 day]
Determine the number of patients who listened the message in totality. [1 day]
Compare the percentage of patients with a sensation of time distortion [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy		France	54519

Sponsors and Collaborators

Institut de Cancérologie de Lorraine

Investigators

Principal Investigator: CRETINEAU Nathalie, Md, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de Cancérologie de Lorraine

ClinicalTrials.gov Identifier:

NCT02822625

Other Study ID Numbers:

2016-A00234-47

First Posted:

Jul 4, 2016

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Institut de Cancérologie de Lorraine

Capsaicin

QUTENZA®

Hypnosis

Peripheral Neuropathic

Additional relevant MeSH terms:

Hypnotics and Sedatives

Study Results

No Results Posted as of Apr 7, 2022