LIPIDOXA: Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Occurrence of painful neuropathy Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory. |
Device: Thermotest
Device: von Frey hairs
|
Outcome Measures
Primary Outcome Measures
- Thermal thresholds [Three to six months]
Four thermal thresholds are assessed by a Thermotest (Somedic AB): cold perception threshold warm perception threshold cold pain threshold warm pain threshold
Secondary Outcome Measures
- Tactile sensitivity [Three to six months]
Tactile sensitivity is assessed with von Frey hairs.
Other Outcome Measures
- Characterization of pain neuropathy [Three to six months]
Neuropathic Pain Symptom Inventory (NPSI questionnaire) is used.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient newly traeted with oxaliplatin
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Patient suffering from any type of cancer treated with oxaliplatin
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Man or Woman over 18
Exclusion Criteria:
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Patient with brain or leptomeningeal metastases
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Patient previously treated with cisplatin
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Patient addicted to alcohol
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Diabetic patient with peripheral neurological disorders
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Patient receiving calcium or magnesium salts intravenously
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Patient suffering from peripheral neuropathy
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Patient suffering from psychiatric disorders
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Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Paris Saint Joseph | Paris | Ile de France | France | 75014 |
Sponsors and Collaborators
- Groupe Hospitalier Paris Saint Joseph
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Attal N, Bouhassira D, Gautron M, Vaillant JN, Mitry E, Lepère 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.
- 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. Epub 2007 Sep 12.
- 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. Review.
- Massicot F, Hache G, David L, Chen D, Leuxe C, Garnier-Legrand L, Rat P, Laprévote O, Coudoré 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.
- LIPIDOXA