NeuropathyINSULOXNCT02340403
Exploration by NMR Spectroscopy of the Choline Concentrations in the Insular Cortex of Patients Suffering of Neuropathic Pain Induced by Oxaliplatin
A study testing NMR Spectroscopy in people with Neuropathy and Painful, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling neuropathic pain that can last for months or even years after the end of chemotherapy. Currently, there is no effective neuroprotective treatment to prevent or relieve this pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Painful
- What is being tested?
- NMR Spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2014to 27 Aug 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
- Oxaliplatin treated patient and suffering from neuropathic pain
- Chemotherapy (oxaliplatin based) ended
- Pain VAS ≥ 3/10, 1 month after the chemotherapy end
- DN4 interview score ≥ 3/7, 1 month after the chemotherapy end
- Oxaliplatin treated patient without neuropathic pain
- Chemotherapy (oxaliplatin based) ended
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- Pain VAS < 3/10, 1 month after the chemotherapy end
- DN4 interview score < 3/7, 1 month after the chemotherapy end
- All patients
- right-handed
- No contrindication to MRI
- Free, written and informed consent
- Affiliated to the french health system
- Effective contraception for male or female of childbearing age
- Performance score (WHO) ≤ 2
Who cannot join
- Age < 18
- Left-handed
- BMI > 30 kg/m²
- Amputees of all or part of an upper limb
- Diabetic patient
- Painful events scheduled after enrollment (eg. surgical resection)
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- Neurological diseases (eg Parkinson's disease, stroke, migraine, fibromyalgia ...)
- Chronic pain history before chemotherapy
- Analgesic treatment being other than paracetamol and weak opioids
- Alcohol consumption >3 units/day (30 g/day) for men and >2 units/day (20 g/day) for women
- Any unbalanced progressive disease (hepatic failure, renal impairment (creatinine clearance <30 mL/min), respiratory failure, congestive heart failure, myocardial infarction within the past 6 months ...)
- All active cancer
- Patient with a pacemaker, a cochlear implant, metal implants, or any other magnetic element
- Claustrophobia
- Pregnant or lactation
- Legal incapacity (person deprived of liberty or guardianship)
- Psychological, social, family or geographical reasons incompatible with the study
- Already included in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling neuropathic pain that can last for months or even years after the end of chemotherapy. Currently, there is no effective neuroprotective treatment to prevent or relieve this pain. The only strategy is the reduction of oxaliplatin doses or premature discontinuation of therapy, with the risk of burdening the prognosis for remission. Thus, a better understanding of the pathophysiology of these iatrogenic neuropathies appears necessary in order to discover new potential therapeutic targets.
Preclinical works were able to demonstrate important metabolic changes in certain brain structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of choline concentration has been found in the posterior insular cortex of neuropathic animals compared with control animals. Furthermore, the concentrations of choline were positively correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would involve the posterior insular cortex and would be associated with an increase in choline concentration at this level. Clinical translation of these preclinical results is feasible in practice since choline concentration can be determined in the brain by non-invasive magnetic resonance spectroscopy.
Read the detailed description
The objective of this study is to demonstrate a significant increase in choline concentration in the insular cortex of patients with an oxaliplatin induced neuropathy. Other objectives will assess the correlation between metabolite concentrations in the insular cortex and frequency / intensity of pain and neuropathic symptoms, cold and heat-induced pain and comorbidities (anxiety, pain, quality of life).
- Conditions
- Neuropathy, Painful
- Being tested
- NMR Spectroscopy
- Keywords
- Neuropathy, Oxaliplatin, Insula, choline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMR SpectroscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin and neuropathic pain | Experimental | The objective of this study is to demonstrate a significant increase in choline concentration in the insular cortex of patients with an oxaliplatin induced neuropathy. Other objectives will assess the correlation between metabolite concentrations in the insular cortex and frequency / intensity of pain and neuropathic symptoms, cold and heat-induced pain and comorbidities (anxiety, pain, quality of life). Receives: Procedure: NMR Spectroscopy |
| Oxaliplatin without neuropathic pain | Other | The objective of this study is to demonstrate a significant increase in choline concentration in the insular cortex of patients with an oxaliplatin induced neuropathy. Other objectives will assess the correlation between metabolite concentrations in the insular cortex and frequency / intensity of pain and neuropathic symptoms, cold and heat-induced pain and comorbidities (anxiety, pain, quality of life). Receives: Procedure: NMR Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choline concentration assessed by NMR spectroscopy in the posterior insula
Measured: 1 month after chemotherapy end
Secondary outcomes (10)
Metabolite concentrations assessed by NMR spectroscopy in the posterior insula
Metabolite (choline, myo-inositol, N-acétylaspartate, créatine, glutamate/glutamine, lactate and taurine)
Measured: 1 month and 6 months after chemotherapy end
Pain intensity (VAS and BPI questionnaire)
(VAS and BPI questionnaire)
Measured: 1 month and 6 months after chemotherapy end
Neuropathic pain diagnostic 9DN4 interview questionnaire)
Measured: 1 month and 6 months after chemotherapy end
Neuropathic pain intensity (NPSI questionnaire)
NPSI questionnaire
Measured: 1 month and 6 months after chemotherapy end
BPI questionnaire
Measured: 1 month and 6 months after chemotherapy end
Quantitative sensory threshold (cold, heat, vibration)
Measured: 1 month and 6 months after chemotherapy end
Neuropathy grade
Measured: 1 month and 6 months after chemotherapy end
Anxiety and depression symptoms (HADS questionnaire)
HADS questionnaire
Measured: 1 month and 6 months after chemotherapy end
Intensity of chemotherapy-induced peripheral neuropathy (CIPN20 questionnaire)
CIPN20 questionnaire
Measured: 1 month and 6 months after chemotherapy end
Health related quality of life (QLQ-C30 questionnaire)
(QLQ-C30 questionnaire
Measured: at 1 month and 6 months after chemotherapy end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study start9 Mar 2014
- Primary completion4 Feb 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340403
- Sponsor's protocol ID
- CHU-0217
- Other IDs
- 2013-A01588-37
- Acronym
- INSULOX
- Status last verified
- Dec 2021
- First submitted
- 8 Jan 2015
- Last updated
- 14 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration by NMR Spectroscopy of the Choline Concentrations in the Insular Cortex of Patients Suffering of Neuropathic Pain Induced by Oxaliplatin
- ClinicalTrials.gov ID
- NCT02340403
- Acronym / sponsor ID
- INSULOX / CHU-0217
- Conditions
- Neuropathy, Painful
- Keywords
- Neuropathy, Oxaliplatin, Insula, choline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Mar 2014 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 16 Jan 2015 (estimated)
- 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.
Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling neuropathic pain that can last for months or even years after the end of chemotherapy. Currently, there is no effective neuroprotective treatment to prevent or relieve this pain. The only strategy is the reduction of oxaliplatin doses or premature discontinuation of therapy, with the risk of burdening the prognosis for remission. Thus, a better understanding of the pathophysiology of these iatrogenic neuropathies appears necessary in order to discover new potential therapeutic targets.
Preclinical works were able to demonstrate important metabolic changes in certain brain structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of choline concentration has been found in the posterior insular cortex of neuropathic animals compared with control animals. Furthermore, the concentrations of choline were positively correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would involve the posterior insular cortex and would be associated with an increase in choline concentration at this level. Clinical translation of these preclinical results is feasible in practice since choline concentration can be determined in the brain by non-invasive magnetic resonance spectroscopy.
Detailed description
The objective of this study is to demonstrate a significant increase in choline concentration in the insular cortex of patients with an oxaliplatin induced neuropathy. Other objectives will assess the correlation between metabolite concentrations in the insular cortex and frequency / intensity of pain and neuropathic symptoms, cold and heat-induced pain and comorbidities (anxiety, pain, quality of life).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin and neuropathic pain | Experimental | Procedure: NMR SpectroscopyThe objective of this study is to demonstrate a significant increase in choline concentration in the insular cortex of patients with an oxaliplatin induced neuropathy. Other objectives will assess the correlation between metabolite concentrations in the insular cortex and frequency / intensity of pain and neuropathic symptoms, cold and heat-induced pain and comorbidities (anxiety, pain, quality of life). |
| Oxaliplatin without neuropathic pain | Other | Procedure: NMR SpectroscopyThe objective of this study is to demonstrate a significant increase in choline concentration in the insular cortex of patients with an oxaliplatin induced neuropathy. Other objectives will assess the correlation between metabolite concentrations in the insular cortex and frequency / intensity of pain and neuropathic symptoms, cold and heat-induced pain and comorbidities (anxiety, pain, quality of life). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Oxaliplatin treated patient and suffering from neuropathic pain
- Oxaliplatin treated patient without neuropathic pain
- All patients
Key exclusion criteria (18 listed)
- Age < 18
- Left-handed
- BMI > 30 kg/m²
- Amputees of all or part of an upper limb
- Diabetic patient
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 |
|---|---|---|
| NMR Spectroscopy | Procedure or surgery | Oxaliplatin and neuropathic pain, Oxaliplatin without neuropathic pain |
Primary outcome
Choline concentration assessed by NMR spectroscopy in the posterior insula
Time frame: 1 month after chemotherapy end
10 secondary outcomes
Metabolite concentrations assessed by NMR spectroscopy in the posterior insula
Time frame: 1 month and 6 months after chemotherapy end
Pain intensity (VAS and BPI questionnaire)
Time frame: 1 month and 6 months after chemotherapy end
Neuropathic pain diagnostic 9DN4 interview questionnaire)
Time frame: 1 month and 6 months after chemotherapy end
Neuropathic pain intensity (NPSI questionnaire)
Time frame: 1 month and 6 months after chemotherapy end
BPI questionnaire
Time frame: 1 month and 6 months after chemotherapy end
Quantitative sensory threshold (cold, heat, vibration)
Time frame: 1 month and 6 months after chemotherapy end
Neuropathy grade
Time frame: 1 month and 6 months after chemotherapy end
Anxiety and depression symptoms (HADS questionnaire)
Time frame: 1 month and 6 months after chemotherapy end
Intensity of chemotherapy-induced peripheral neuropathy (CIPN20 questionnaire)
Time frame: 1 month and 6 months after chemotherapy end
Health related quality of life (QLQ-C30 questionnaire)
Time frame: at 1 month and 6 months after chemotherapy end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMR Spectroscopy in people with Neuropathy and Painful, run by University Hospital, Clermont-Ferrand 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 15 inclusion and 18 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: finished, as of the sponsor's last update on 14 Jan 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choline concentration assessed by NMR spectroscopy in the posterior insula (time frame: 1 month after chemotherapy end). 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 14 Jan 2022.