Chemo-induced Neuropathy Clinical Trial
— CANALOXAOfficial title:
Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach: Interest Using the SUDOSCAN® Machine
| Verified date | September 2017 |
| Source | Groupe Hospitalier Paris Saint Joseph |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | June 30, 2017 |
| Est. primary completion date | April 13, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient newly treated 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Hospitalier Paris Saint Joseph |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain | The pain symptoms are evaluated through various semi- objective neuropathy quantification tools (Quantitative Sensory Testing devices)6 : - Le Thermotest (Somedic®) : medical device that measures the thermal sensitivity thresholds to cold and hot: cold sensitivity threshold, threshold of sensitivity to hot, cold pain threshold, pain threshold warm. These stimuli are transmitted by the fiber Adelta and C. Since dysesthesia to thermal stimuli (allodynia in acute and hypoesthesia in chroniqe) are typical of oxaliplatin, Thermotest is fundamental. |
Day 1 | |
| Secondary | NPSI ange of Characterization of pain neuropathy | Questionnaire NPSI (Neuropathic Pain Symptom Inventory) widely used in the field and validated. | Day 1 |