Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin
NCT ID: NCT02169908
Last Updated: 2016-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2014-05-31
2016-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Occurrence of painful neuropathy
Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory.
Thermotest
von Frey hairs
Interventions
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Thermotest
von Frey hairs
Eligibility Criteria
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Inclusion Criteria
* Patient suffering from any type of cancer treated with oxaliplatin
* Man or Woman over 18
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Locations
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Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, France
Countries
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References
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Massicot F, Hache G, David L, Chen D, Leuxe C, Garnier-Legrand L, Rat P, Laprevote O, Coudore F. P2X7 Cell Death Receptor Activation and Mitochondrial Impairment in Oxaliplatin-Induced Apoptosis and Neuronal Injury: Cellular Mechanisms and In Vivo Approach. PLoS One. 2013 Jun 27;8(6):e66830. doi: 10.1371/journal.pone.0066830. Print 2013.
Binder A, Stengel M, Maag R, Wasner G, Schoch R, Moosig F, Schommer B, Baron R. Pain in oxaliplatin-induced neuropathy--sensitisation in the peripheral and central nociceptive system. Eur J Cancer. 2007 Dec;43(18):2658-63. doi: 10.1016/j.ejca.2007.07.030. Epub 2007 Sep 12.
Attal N, Bouhassira D, Gautron M, Vaillant JN, Mitry E, Lepere C, Rougier P, Guirimand F. Thermal hyperalgesia as a marker of oxaliplatin neurotoxicity: a prospective quantified sensory assessment study. Pain. 2009 Aug;144(3):245-252. doi: 10.1016/j.pain.2009.03.024. Epub 2009 May 19.
Cruccu G, Sommer C, Anand P, Attal N, Baron R, Garcia-Larrea L, Haanpaa M, Jensen TS, Serra J, Treede RD. EFNS guidelines on neuropathic pain assessment: revised 2009. Eur J Neurol. 2010 Aug;17(8):1010-8. doi: 10.1111/j.1468-1331.2010.02969.x. Epub 2010 Mar 8.
Other Identifiers
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LIPIDOXA
Identifier Type: -
Identifier Source: org_study_id
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