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

Primary Purpose

Chemotherapy-induced Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nurse interview
Hypnosis sessions
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Strasbourg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Nurse interview

Hypnosis session

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Measure benefits of hypnosis on the neuropathic pain intensity
Measure benefits of hypnosis on a psychotropic treatments
Measure benefits of hypnosis on analgesic treatments
Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
Measure benefits of hypnosis on self- hypnosis in the experimental group
Evaluate the safety in the two arms, due to hypnosis adverse effects, to pain treatment or another reason

Full Information

First Posted
March 9, 2017
Last Updated
October 18, 2021
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03156595
Brief Title
Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies
Acronym
NHYP
Official Title
Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
November 4, 2021 (Anticipated)
Study Completion Date
November 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse interview
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Hypnosis session
Arm Type
Experimental
Arm Description
Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.
Intervention Type
Behavioral
Intervention Name(s)
Nurse interview
Other Intervention Name(s)
Listening time
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis sessions
Intervention Description
Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Measure benefits of hypnosis on the neuropathic pain intensity
Time Frame
Day 28, day 56 and Day 84.
Title
Measure benefits of hypnosis on a psychotropic treatments
Time Frame
Day 0, Day 28, day 56 and Day 84.
Title
Measure benefits of hypnosis on analgesic treatments
Time Frame
Day 0, Day 28, day 56 and Day 84.
Title
Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
Time Frame
Day 84
Title
Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
Time Frame
Day 84
Title
Measure benefits of hypnosis on self- hypnosis in the experimental group
Time Frame
Day 28, Day 56 and D84
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Laudamy
Phone
+33 3 88 11 66 88
Email
anne.laudamy@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
anatta Razafimanantsoa
Phone
+ 33 3 88 11 54 14
Email
anatta.razafimanantsoa@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline MAURER, Nurse
Organizational Affiliation
Strasbourg's University Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raoul HERBRECHT, MD
Organizational Affiliation
Strasbourg's University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Strasbourg Hospital
City
Strabsourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul HERBRECHT, MD
Email
raoul.herbrecht@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Caroline MAURER, Nurse
Email
caroline.maurer@chru-strasbourg.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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