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Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer. However, the development of neuropathic pain under treatment limits its use. These are manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia.
It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2 channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms of neurotoxicity are multifactorial and still imperfectly described.
Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose challenge is to quantify / measure NAION and explained by a biochemical approach, specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that the expected results will be complementary to those of LIPIDOXA.
Main objective:
it is, in cancer patients chronically treated with oxaliplatin (over 5 courses) and exhibiting signs of neuropathy, to correlate the quantitative changes in the thermal sensitivity to hot and cold (Thermotest, Quantitative Sensory Testing QST ) with any changes in the ion conductance chlorine measured by electrophysiological technique (SUDOSCAN).
Secondary objectives:
Methodology :
Prospective study, single center, intervention in routine care. Time study: February 2015 - October 2016
Evaluation of neuropathy by electrophysiological methods (SUDOSCAN) The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance at the skin of the palms and the soles of pieds4,5.
Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain
The pain symptoms was evaluated through various semi-objective neuropathy quantification tools (Quantitative Sensory Testing devices) 6:
Statistical Analysis: Professor Gilles Chatellier, statistician (Clinical Research Unit, Hôpital Européen Georges Pompidou) will bring its expertise in statistical analysis.
NB: For each subject will be awarded an identifier (simple counter: increment as and measurement of inclusions) and the data will be entered on a computer file which will be sent to the statistician in charge of the analysis. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of neuropathic pain with theThermotest device | Device | Measure of painful neuropathy with thermotest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of neuropathy by electrophysiological methods using SUDOSCAN | The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance of the skin on the palm of the hand and soles of the feet2). This can evaluate the neuropathy for quantitative measurement of neuropathic pain | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain | The pain symptoms are evaluated through various semi- objective neuropathy quantification tools (Quantitative Sensory Testing devices)6 : - Le Thermotest (Somedic®) : medical device that measures the thermal sensitivity thresholds to cold and hot: cold sensitivity threshold, threshold of sensitivity to hot, cold pain threshold, pain threshold warm. These stimuli are transmitted by the fiber Adelta and C. Since dysesthesia to thermal stimuli (allodynia in acute and hypoesthesia in chroniqe) are typical of oxaliplatin, Thermotest is fundamental. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| COUDORE Francois, MD | Fondation Hôpital Saint-Joseph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Paris Saint Joseph | Paris | Île-de-France Region | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30363900 | Derived | Delmotte JB, Tutakhail A, Abdallah K, Reach P, D'Ussel M, Deplanque G, Beaussier H, Coudore F. Electrochemical Skin Conductance as a Marker of Painful Oxaliplatin-Induced Peripheral Neuropathy. Neurol Res Int. 2018 Sep 27;2018:1254602. doi: 10.1155/2018/1254602. eCollection 2018. |
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| Assessment of neuropathic pain with SUDOSCAN device | Device | Measure of painful neuropathy with sudoscan Devices |
|
| Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory. | Device | Measure of painful neuropathy with Neuropathic Pain Symptom Inventory. |
|
| Day 1 |
| NPSI ange of Characterization of pain neuropathy | Questionnaire NPSI (Neuropathic Pain Symptom Inventory) widely used in the field and validated. | Day 1 |