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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|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|
Occurrence of painful neuropathy
Assessment of neuropathic pain with two devices (Thermotest and von Frey hairs) and with the Neuropathic Pain Symptom Inventory.
Device: von Frey hairs
- 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
- Tactile sensitivity [ Time Frame: Three to six months ]Tactile sensitivity is assessed with von Frey hairs.
- Characterization of pain neuropathy [ Time Frame: Three to six months ]Neuropathic Pain Symptom Inventory (NPSI questionnaire) is used.
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
|Groupe Hospitalier Paris Saint Joseph|
|Paris, Ile de France, France, 75014|