Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin

Study Overview
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Brief Summary
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The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical manifestations and pathophysiological mechanisms potentially involved have also been described in humans (Andreas 2007) (Attal 2009). The investigators team plans to conduct a translational clinicobiological research to explain the nature of the biochemical and molecular mechanisms of the development of oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of 20 patients. The main objective of this pilot study is to evaluate the occurrence of acute and chronic neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization of this pain is based on validated tests (Cruccu 2010). Moreover, the biochemical changes related to oxidative stress and those related to cellular lipid composition are characterized in these patients.

Official Title
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LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen

Conditions
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Digestive Cancer, Gynecological Cancer

Intervention / Treatment
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* Device: Thermotest
* Device: von Frey hairs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient newly traeted with oxaliplatin Patient suffering from any type of cancer treated with oxaliplatin Man or Woman over 18 Exclusion Criteria: Patient with brain or leptomeningeal metastases Patient previously treated with cisplatin Patient addicted to alcohol Diabetic patient with peripheral neurological disorders Patient receiving calcium or magnesium salts intravenously Patient suffering from peripheral neuropathy Patient suffering from psychiatric disorders Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Occurrence of painful neuropathy<br>Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory. | Device: Thermotest<br> <br> Device: von Frey hairs<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal thresholds | Four thermal thresholds are assessed by a Thermotest (Somedic AB): cold perception threshold warm perception threshold cold pain threshold warm pain threshold | Three to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tactile sensitivity | Tactile sensitivity is assessed with von Frey hairs. | Three to six months |