Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05875610
Status:
RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-05-16
Brief Title:
Preventive Approach Using Venlafaxine
Sponsor:
Mit Ghamr Oncology Center
Organization:
Mit Ghamr Oncology Center
Study Overview
Official Title:
Clinical Study on Chemotherapy Induced Peripheral Neuropathy Preventive Approach Using Venlafaxine
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients
Detailed Description:
Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders A wide range of neurologic complications can associate antineoplastic drug treatment Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity Moreover taxanes paclitaxel are also associated with neurotoxicity In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine 375 mg extended release twice daily from day 2 to 11 or placebo however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice until additional supporting data become available patients will be randomly assigned to treatment arms
1 Arm A to receive venlafaxine hydrochloride 75 mg Effexor XR 75mg once daily from day 1 to day 7 to avoid need of dose tapering
2 Arm B to receive Gabapentin 100-400 mg once daily from day 1 to day 7
1 Arm A to receive venlafaxine hydrochloride 75 mg Effexor XR 75mg once daily from day 1 to day 7 to avoid need of dose tapering
2 Arm B to receive Gabapentin 100-400 mg once daily from day 1 to day 7
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None