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NCT Number: NCT02340403

Exploration by NMR Spectroscopy of the Choline Concentrations in the Insular Cortex of Patients Suffering of Neuropathic Pain Induced by Oxaliplatin

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.

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Key information

Conditions

Neuropathy Neurologic Manifestations Pain Painful Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

NMR Spectroscopy

Procedure

Primary outcomes

  1. Choline concentration assessed by NMR spectroscopy in the posterior insula

    Time frame: 1 month after chemotherapy end

Secondary outcomes

  1. Metabolite concentrations assessed by NMR spectroscopy in the posterior insula

    Time frame: 1 month and 6 months after chemotherapy end

    Metabolite (choline, myo-inositol, N-acétylaspartate, créatine, glutamate/glutamine, lactate and taurine)

  2. Pain intensity (VAS and BPI questionnaire)

    Time frame: 1 month and 6 months after chemotherapy end

    (VAS and BPI questionnaire)

  3. Neuropathic pain diagnostic 9DN4 interview questionnaire)

    Time frame: 1 month and 6 months after chemotherapy end

  4. Neuropathic pain intensity (NPSI questionnaire)

    Time frame: 1 month and 6 months after chemotherapy end

    NPSI questionnaire

  5. BPI questionnaire

    Time frame: 1 month and 6 months after chemotherapy end

  6. Quantitative sensory threshold (cold, heat, vibration)

    Time frame: 1 month and 6 months after chemotherapy end

  7. Neuropathy grade

    Time frame: 1 month and 6 months after chemotherapy end

  8. Anxiety and depression symptoms (HADS questionnaire)

    Time frame: 1 month and 6 months after chemotherapy end

    HADS questionnaire

  9. Intensity of chemotherapy-induced peripheral neuropathy (CIPN20 questionnaire)

    Time frame: 1 month and 6 months after chemotherapy end

    CIPN20 questionnaire

  10. Health related quality of life (QLQ-C30 questionnaire)

    Time frame: at 1 month and 6 months after chemotherapy end

    (QLQ-C30 questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: INSULOX

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jan 16, 2015
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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