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

NCT02822625 | Completed Phase 3

• 1 other identifier: 2016-A00234-47
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Capsaicin; QUTENZA®; Hypnosis; Peripheral Neuropathic

Outcome Measures

Primary Outcomes (1)

• Compare pain induced by patch QUTENZA®

  Pain will be evaluated by a numerical scale before, just after, and after installation of the patch

  1 day

Secondary Outcomes (4)

• Compare anxiety induced by patch QUTENZA®

  1 day

• 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

Study Arms (3)

arm 1

EXPERIMENTAL

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

Drug: QUTENZA®

arm 2

ACTIVE COMPARATOR

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

arm 3

PLACEBO COMPARATOR

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

Interventions

QUTENZA® DRUG

arm 1; arm 2; arm 3

hypnotic message OTHER

arm 2

music therapy OTHER

arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

• 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.

  PMID: 34044838 RESULT

MeSH Terms

Conditions

Pain; Neuritis

Interventions

Capsaicin; Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• CRETINEAU Nathalie, Md

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: August 30, 2016
• Primary Completion: July 10, 2019
• Study Completion: July 13, 2019
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)