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

March 29, 2022 updated by: Institut de Cancérologie de Lorraine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: music therapy
Drug: QUTENZA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare pain induced by patch QUTENZA®
Time Frame: 1 day
Pain will be evaluated by a numerical scale before, just after, and after installation of the patch
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2016

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

July 13, 2019

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00234-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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