Chemotherapy-induced NeuropathyNHYPNCT03156595
Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies
A study testing Nurse interview and Hypnosis sessions in people with Chemotherapy-induced Neuropathy, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neuropathy
- What is being tested?
- Nurse interview and Hypnosis sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2017to 4 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- French efficient understanding
- With health insurance coverage
- availability during all the study
- With efficient contraception for women of childbearing age
Who cannot join
- 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
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- Mental retardation
- Allergy to EMG's electrodes
- Unable to consent, under tutelage or curatorship or judiciary safeguard
- Pregnant or nursing woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Strasbourg Hospital
Strabsourg, 67091
Raoul HERBRECHT, MD, raoul.herbrecht@chru-strasbourg.fr
Caroline MAURER, Nurse, caroline.maurer@chru-strasbourg.fr
About this study
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.
- Conditions
- Chemotherapy-induced Neuropathy
- Being tested
- Nurse interview, Hypnosis sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse interviewBehavioural
Also called Listening time
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 sessionsBehavioural
Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
| Study group | Role | What they receive |
|---|---|---|
| Nurse interview | Placebo comparator | 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. Receives: Behavioral: Nurse interview |
| Hypnosis session | Experimental | Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning. Receives: Behavioral: Hypnosis sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 84
Measure benefits of hypnosis on the neuropathic pain intensity
Measured: Day 28, day 56 and Day 84.
Measure benefits of hypnosis on a psychotropic treatments
Measured: Day 0, Day 28, day 56 and Day 84.
Measure benefits of hypnosis on analgesic treatments
Measured: Day 0, Day 28, day 56 and Day 84.
Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
Measured: Day 84
Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
Measured: Day 84
Measure benefits of hypnosis on self- hypnosis in the experimental group
Measured: Day 28, Day 56 and D84
Evaluate the safety in the two arms, due to hypnosis adverse effects, to pain treatment or another reason
Measured: Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start4 Aug 2017
- Primary completion4 Nov 2021 (estimated)
- Study completion4 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline MAURER, Nurse, Study chair, Strasbourg's University HospitalsRaoul HERBRECHT, MD, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156595
- Sponsor's protocol ID
- PHRIP 2015 - HUS n°6395
- Acronym
- NHYP
- Status last verified
- Oct 2021
- First submitted
- 9 Mar 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies
- ClinicalTrials.gov ID
- NCT03156595
- Acronym / sponsor ID
- NHYP / PHRIP 2015 - HUS n°6395
- Conditions
- Chemotherapy-induced Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 4 Nov 2021 (estimated)
- Study completion
- 4 Nov 2021 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse interview | Placebo comparator | Behavioral: Nurse interviewPersonal 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 | Experimental | Behavioral: Hypnosis sessionsHypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse interviewAlso: Listening timePersonal 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. | Behavioural | Nurse interview |
| Hypnosis sessionsHypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning. | Behavioural | Hypnosis session |
Primary outcome
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
9 secondary outcomes
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
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
Measure benefits of hypnosis on the neuropathic pain intensity
Time frame: Day 28, day 56 and Day 84.
Measure benefits of hypnosis on a psychotropic treatments
Time frame: Day 0, Day 28, day 56 and Day 84.
Measure benefits of hypnosis on analgesic treatments
Time frame: Day 0, Day 28, day 56 and Day 84.
Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
Time frame: Day 84
Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
Time frame: Day 84
Measure benefits of hypnosis on self- hypnosis in the experimental group
Time frame: Day 28, Day 56 and D84
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline MAURER, Nurse study chair
Strasbourg's University Hospitals
Raoul HERBRECHT, MD principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse interview and Hypnosis sessions in people with Chemotherapy-induced Neuropathy, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Laudamy (+33 3 88 11 66 88, anne.laudamy@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.