An interventional study of NMR Spectroscopy in Neuropathy and Painful, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-14.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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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This study's enrollment of 42 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
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Oxaliplatin treated patient and suffering from neuropathic pain
Oxaliplatin treated patient without neuropathic pain
All patients
Exclusion Criteria:
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).
Procedure: NMR 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).
Procedure: NMR Spectroscopy
Choline concentration assessed by NMR spectroscopy in the posterior insula
Time frame: 1 month after chemotherapy end
Metabolite concentrations assessed by NMR spectroscopy in the posterior insula
Metabolite (choline, myo-inositol, N-acétylaspartate, créatine, glutamate/glutamine, lactate and taurine)
Time frame: 1 month and 6 months after chemotherapy end
Pain intensity (VAS and BPI questionnaire)
(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)
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)
HADS questionnaire
Time frame: 1 month and 6 months after chemotherapy end
Intensity of chemotherapy-induced peripheral neuropathy (CIPN20 questionnaire)
CIPN20 questionnaire
Time frame: 1 month and 6 months after chemotherapy end
Health related quality of life (QLQ-C30 questionnaire)
(QLQ-C30 questionnaire
Time frame: at 1 month and 6 months after chemotherapy end
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand