Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin

Digestive Cancer Clinical Trial

— LIPIDOXA  

Official title:

LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169908
• Other study ID #: LIPIDOXA
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: March 9, 2016
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Committee for the protection of Persons
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Digestive Cancer
• Gynecological Cancer
• Neuralgia

Intervention

Device:
• Thermotest

• von Frey hairs

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (4)

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):245-52. doi: 10.1016/j.pain.2009.03.024. Epub 2009 May 19. — View 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. Epub 2007 Sep 12. — View 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. Review. — View Citation

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. Print 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Characterization of pain neuropathy	Neuropathic Pain Symptom Inventory (NPSI questionnaire) is used.	Three to six months	No
Primary	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	No
Secondary	Tactile sensitivity	Tactile sensitivity is assessed with von Frey hairs.	Three to six months	No