Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies
NHYP
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
August 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2021
CompletedOctober 19, 2021
October 1, 2021
4.3 years
March 9, 2017
October 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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.
- +4 more secondary outcomes
Study Arms (2)
Nurse interview
PLACEBO COMPARATORPersonal 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 session
EXPERIMENTALHypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.
Interventions
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 a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Strasbourg Hospital
Strabsourg, 67091, France
Study Officials
- STUDY CHAIR
Caroline MAURER, Nurse
Strasbourg's University Hospitals
- PRINCIPAL INVESTIGATOR
Raoul HERBRECHT, MD
Strasbourg's University Hospitals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2017
First Posted
May 17, 2017
Study Start
August 4, 2017
Primary Completion
November 4, 2021
Study Completion
November 4, 2021
Last Updated
October 19, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share