Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin

Not Applicable

Completed

• Conditions: Gynecological Cancer; Digestive Cancer
• Interventions: Device: Thermotest; Device: von Frey hairs

• Registration Number: NCT02169908
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Primary Completion: 2015-06
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Occurrence of painful neuropathy	Thermotest	Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory.
Occurrence of painful neuropathy	von Frey hairs	Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Tactile sensitivity	Three to six months	Tactile sensitivity is assessed with von Frey hairs.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, Ile de France, France