Clinical trial NCT02822625: Efficacity of a Standardized Hypnotic Message During the Application of a Qutenza (Capsaicin) 8% Patch
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Capsaicin
QUTENZA®
Hypnosis
Peripheral Neuropathic
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare pain induced by patch QUTENZA®
timeFrame: 1 day
Secondary outcomes:
measure: Compare anxiety induced by patch QUTENZA®
timeFrame: 1 day
measure: Compare the real time of application of the patch
timeFrame: 1 day
measure: Determine the number of patients who listened the message in totality.
timeFrame: 1 day
measure: Compare the percentage of patients with a sensation of time distortion
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: CRETINEAU Nathalie, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Etienne R, Laurent M, Henry A, Bioy A, Salleron J, Schohn CH, Cretineau N. Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial. BMC Complement Med Ther. 2021 May 27;21(1):154. doi: 10.1186/s12906-021-03329-8.