Clinical trial NCT02169908: Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin
Official title: LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Cancer
Gynecological Cancer
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Thermal thresholds
timeFrame: Three to six months
Secondary outcomes:
measure: Tactile sensitivity
timeFrame: Three to six months
Other outcomes:
measure: Characterization of pain neuropathy
timeFrame: Three to six months
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile de France
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.