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Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin (LIPIDOXA)

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ClinicalTrials.gov Identifier: NCT02169908
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris 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.


Condition or disease Intervention/treatment Phase
Digestive Cancer Gynecological Cancer Device: Thermotest Device: von Frey hairs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen
Study Start Date : May 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Occurrence of painful neuropathy
Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory.
Device: Thermotest
Device: von Frey hairs



Primary Outcome Measures :
  1. Thermal thresholds [ Time Frame: 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 :
  1. Tactile sensitivity [ Time Frame: Three to six months ]
    Tactile sensitivity is assessed with von Frey hairs.


Other Outcome Measures:
  1. Characterization of pain neuropathy [ Time Frame: Three to six months ]
    Neuropathic Pain Symptom Inventory (NPSI questionnaire) is used.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169908


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile de France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Publications:
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02169908    
Other Study ID Numbers: LIPIDOXA
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations