Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach

NCT02827916 | Completed DMC

• 1 other identifier: CANALOXA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer. However, the development of neuropathic pain under treatment limits its use. These are manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia. It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2 channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms of neurotoxicity are multifactorial and still imperfectly described. Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose challenge is to quantify / measure NAION and explained by a biochemical approach, specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that the expected results will be complementary to those of LIPIDOXA.

Conditions

Peripheric Neuropathy; Chemo-induced Neuropathy

Outcome Measures

Primary Outcomes (1)

• Evaluation of neuropathy by electrophysiological methods using SUDOSCAN

  The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance of the skin on the palm of the hand and soles of the feet2). This can evaluate the neuropathy for quantitative measurement of neuropathic pain

  Day 1

Secondary Outcomes (2)

• Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain

  Day 1

• NPSI ange of Characterization of pain neuropathy

  Day 1

Study Arms (1)

All patients

EXPERIMENTAL

Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory.

Device: Assessment of neuropathic pain with theThermotest device; Device: Assessment of neuropathic pain with SUDOSCAN device; Device: Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.

Interventions

Assessment of neuropathic pain with theThermotest device DEVICE

Measure of painful neuropathy with thermotest

All patients

Assessment of neuropathic pain with SUDOSCAN device DEVICE

Measure of painful neuropathy with sudoscan Devices

All patients

Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory. DEVICE

Measure of painful neuropathy with Neuropathic Pain Symptom Inventory.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient newly treated 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• Delmotte JB, Tutakhail A, Abdallah K, Reach P, D'Ussel M, Deplanque G, Beaussier H, Coudore F. Electrochemical Skin Conductance as a Marker of Painful Oxaliplatin-Induced Peripheral Neuropathy. Neurol Res Int. 2018 Sep 27;2018:1254602. doi: 10.1155/2018/1254602. eCollection 2018.

  PMID: 30363900 DERIVED

Study Officials

• COUDORE Francois, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 11, 2016
• Study Start: April 4, 2016
• Primary Completion: April 13, 2016
• Study Completion: June 30, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

FR (1)