Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin
LIPIDOXA
LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 10, 2016
March 1, 2016
1.1 years
June 18, 2014
March 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Tactile sensitivity
Three to six months
Other Outcomes (1)
Characterization of pain neuropathy
Three to six months
Study Arms (1)
Occurrence of painful neuropathy
OTHERAssessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory.
Interventions
Eligibility Criteria
You may qualify if:
- Patient newly traeted with oxaliplatin
- Patient suffering from any type of cancer treated with oxaliplatin
- Man or Woman over 18
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
Related Publications (4)
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.
PMID: 23826152BACKGROUNDBinder 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.
PMID: 17855072BACKGROUNDAttal 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.
PMID: 19457614BACKGROUNDCruccu 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.
PMID: 20298428BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 23, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Study Completion
March 1, 2016
Last Updated
March 10, 2016
Record last verified: 2016-03