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.
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 (37.5 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 X.R) 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Venlafaxine 75 mg extended release capsules for a 7-days duration
Gabapentin 400 mg capsules
Mit Ghamr Oncology Center
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGThe incidence of grade II or more peripheral neuropathy
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)
Time frame: 4 months
The EORTC QLQ-CIPN20 subscales
Sensory subscale, motor, and autonomic subscales of CIPN20
Time frame: 4 months
Pain Severity
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Time frame: 4 months
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