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

Chemotherapy-induced Neuropathy Clinical Trial

— NHYP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156595
• Other study ID #: PHRIP 2015 - HUS n°6395
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2017
• Est. completion date: November 4, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: Anne Laudamy
• Phone: +33 3 88 11 66 88
• Email: anne.laudamy[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Neuropathy
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• 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.
• Hypnosis sessions
Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.

Locations

Country	Name	City	State
France	University Strasbourg Hospital	Strabsourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Measure benefits of hypnosis on the neuropathic pain intensity		Day 28, day 56 and Day 84.
Secondary	Measure benefits of hypnosis on a psychotropic treatments		Day 0, Day 28, day 56 and Day 84.
Secondary	Measure benefits of hypnosis on analgesic treatments		Day 0, Day 28, day 56 and Day 84.
Secondary	Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength		Day 84
Secondary	Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy		Day 84
Secondary	Measure benefits of hypnosis on self- hypnosis in the experimental group		Day 28, Day 56 and D84
Secondary	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