Digestive Cancer, Gynecological Cancer
Conditions
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.
Interventions
DEVICEThermotest
DEVICEvon Frey hairs
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tactile sensitivity | Three to six months | Tactile sensitivity is assessed with von Frey hairs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Characterization of pain neuropathy | Three to six months | Neuropathic Pain Symptom Inventory (NPSI questionnaire) is used. |
Countries
France
Outcome results
None listed