- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03156595
Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies (NHYP)
Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected.
Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them.
the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.
The aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Laudamy
- Phone Number: +33 3 88 11 66 88
- Email: anne.laudamy@chru-strasbourg.fr
Study Contact Backup
- Name: anatta Razafimanantsoa
- Phone Number: + 33 3 88 11 54 14
- Email: anatta.razafimanantsoa@chru-strasbourg.fr
Study Locations
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-
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Strabsourg, France, 67091
- Recruiting
- University Strasbourg Hospital
-
Contact:
- Raoul HERBRECHT, MD
- Email: raoul.herbrecht@chru-strasbourg.fr
-
Contact:
- Caroline MAURER, Nurse
- Email: caroline.maurer@chru-strasbourg.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Minimum age :18 years
- Chemiotherapy- induced chronic neuropathies for at least 2 months with a DN4 score >4
- Failure of classic treatment used to relief neuropathic
- Having stopped chemotherapy treatment and being in complete or partial response or in tumoral stability
- Without any planed chemiotherapy during the study
- Having signed a written informed consent.
- French efficient understanding
- With health insurance coverage
- availability during all the study
- With efficient contraception for women of childbearing age
Exclusion Criteria:
- No participation to another study at the same time
- Suffering from neuropathy before having chemotherapy
- Other disease that may cause neuropathy
- deafness
- Any medicine that could cause neuropathy
- Neurological or psychiatrical disease past or present
- Mental retardation
- Allergy to EMG's electrodes
- Unable to consent, under tutelage or curatorship or judiciary safeguard
- Pregnant or nursing woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Nurse interview
Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment.
(If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
|
Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment.
(If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
Other Names:
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Experimental: Hypnosis session
Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.
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Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the sensitive dimension of the quality of life of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
Time Frame: Day 84
|
Day 84
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the motor dimension of the quality of life of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
Time Frame: Day 84
|
Day 84
|
Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the loss of autonomy of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
Time Frame: Day 84
|
Day 84
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Measure benefits of hypnosis on the neuropathic pain intensity
Time Frame: Day 28, day 56 and Day 84.
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Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on a psychotropic treatments
Time Frame: Day 0, Day 28, day 56 and Day 84.
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Day 0, Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on analgesic treatments
Time Frame: Day 0, Day 28, day 56 and Day 84.
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Day 0, Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
Time Frame: Day 84
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Day 84
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Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
Time Frame: Day 84
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Day 84
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Measure benefits of hypnosis on self- hypnosis in the experimental group
Time Frame: Day 28, Day 56 and D84
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Day 28, Day 56 and D84
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Evaluate the safety in the two arms, due to hypnosis adverse effects, to pain treatment or another reason
Time Frame: Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
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Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
|
Collaborators and Investigators
Investigators
- Study Chair: Caroline MAURER, Nurse, Strasbourg's University Hospitals
- Principal Investigator: Raoul HERBRECHT, MD, Strasbourg's University Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRIP 2015 - HUS n°6395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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