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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Chemotherapy-induced Neuropathy

Treatments: Behavioral: Nurse interview; Behavioral: Hypnosis sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03156595

PHRIP 2015 - HUS n°6395

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups, including a placebo group

Nurse interview

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Nurse interview

Hypnosis session

Experimental group

Description:

Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.

Treatment:

Behavioral: Hypnosis sessions