PainPhase 3ENHYZANCT02822625
Efficacity of a Standardized Hypnotic Message During the Application of a Qutenza (Capsaicin) 8% Patch
A Phase 3 study testing QUTENZA®, hypnotic message and music therapy in people with Pain, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- QUTENZA®, hypnotic message and music therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2016to 13 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- QUTENZA®, hypnotic message, music therapy
- Keywords
- Capsaicin, QUTENZA®, Hypnosis, Peripheral Neuropathic
- Medical subject headings
- Pain, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUTENZA®Drug
hypnotic messageOther
music therapyOther
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care. Receives: 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 Receives: 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 Receives: Drug: QUTENZA®; Other: music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare pain induced by patch QUTENZA®
Pain will be evaluated by a numerical scale before, just after, and after installation of the patch
Measured: 1 day
Secondary outcomes (4)
Compare anxiety induced by patch QUTENZA®
Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch
Measured: 1 day
Compare the real time of application of the patch
Measured: 1 day
Determine the number of patients who listened the message in totality.
Measured: 1 day
Compare the percentage of patients with a sensation of time distortion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start30 Aug 2016
- Primary completion10 Jul 2019
- Study completion13 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CRETINEAU Nathalie, Md, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822625
- Sponsor's protocol ID
- 2016-A00234-47
- Acronym
- ENHYZA
- Status last verified
- Mar 2022
- First submitted
- 30 Jun 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34044838
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02822625
- Acronym / sponsor ID
- ENHYZA / 2016-A00234-47
- Conditions
- Pain
- Keywords
- Capsaicin, QUTENZA®, Hypnosis, Peripheral Neuropathic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 13 Jul 2019 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: QUTENZA®Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care. |
| arm 2 | Active comparator | Drug: QUTENZA®, Other: hypnotic messagePatients, 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 |
| arm 3 | Placebo comparator | Drug: QUTENZA®, Other: music therapyPatients, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUTENZA® | Drug | arm 1, arm 2, arm 3 |
| hypnotic message | Other | arm 2 |
| music therapy | Other | arm 3 |
Primary outcome
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
4 secondary outcomes
Compare anxiety induced by patch QUTENZA®
Time frame: 1 day
Compare the real time of application of the patch
Time frame: 1 day
Determine the number of patients who listened the message in totality.
Time frame: 1 day
Compare the percentage of patients with a sensation of time distortion
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Results publication: PubMed 34044838Etienne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CRETINEAU Nathalie, Md principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QUTENZA®, hypnotic message and music therapy in people with Pain, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare pain induced by patch QUTENZA® (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.