Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies

Study Overview
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Brief Summary
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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.

Official Title
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Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies

Conditions
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Chemotherapy-induced Neuropathy

Intervention / Treatment
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* Behavioral: Nurse interview
* Behavioral: Hypnosis sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Nurse interview<br>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. | Behavioral: Nurse interview<br>* 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.<br>* Other names: Listening time;|
| Experimental: Hypnosis session<br>Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning. | Behavioral: Hypnosis sessions<br>* Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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. |  | Day 84 | 
| Measure benefits of hypnosis on the neuropathic pain intensity |  | Day 28, day 56 and Day 84. | 
| Measure benefits of hypnosis on a psychotropic treatments |  | Day 0, Day 28, day 56 and Day 84. | 
| Measure benefits of hypnosis on analgesic treatments |  | Day 0, Day 28, day 56 and Day 84. | 
| Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength |  | Day 84 | 
| Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy |  | Day 84 | 
| Measure benefits of hypnosis on self- hypnosis in the experimental group |  | Day 28, Day 56 and D84 | 
| Evaluate the safety in the two arms, due to hypnosis adverse effects, to pain treatment or another reason |  | Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event |