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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01588-37 | Registry Identifier | 2013-A01588-37 |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMR Spectroscopy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Choline concentration assessed by NMR spectroscopy in the posterior insula | 1 month after chemotherapy end |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite concentrations assessed by NMR spectroscopy in the posterior insula | Metabolite (choline, myo-inositol, N-acétylaspartate, créatine, glutamate/glutamine, lactate and taurine) | 1 month and 6 months after chemotherapy end |
| Pain intensity (VAS and BPI questionnaire) |
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Inclusion Criteria:
Oxaliplatin treated patient and suffering from neuropathic pain
Oxaliplatin treated patient without neuropathic pain
All patients
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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(VAS and BPI questionnaire) |
| 1 month and 6 months after chemotherapy end |
| Neuropathic pain diagnostic 9DN4 interview questionnaire) | 1 month and 6 months after chemotherapy end |
| Neuropathic pain intensity (NPSI questionnaire) | NPSI questionnaire | 1 month and 6 months after chemotherapy end |
| BPI questionnaire | 1 month and 6 months after chemotherapy end |
| Quantitative sensory threshold (cold, heat, vibration) | 1 month and 6 months after chemotherapy end |
| Neuropathy grade | 1 month and 6 months after chemotherapy end |
| Anxiety and depression symptoms (HADS questionnaire) | HADS questionnaire | 1 month and 6 months after chemotherapy end |
| Intensity of chemotherapy-induced peripheral neuropathy (CIPN20 questionnaire) | CIPN20 questionnaire | 1 month and 6 months after chemotherapy end |
| Health related quality of life (QLQ-C30 questionnaire) | (QLQ-C30 questionnaire | at 1 month and 6 months after chemotherapy end |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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