NCT05875610

Preventive Approach Using Venlafaxine

Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mit Ghamr Oncology Center · Academic / Other
• Sex: All
• Age: 24 Years – 80 Years
• Healthy volunteers: Accepted

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 (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.

Conditions

• Peripheral Neuropathy Due to Chemotherapy

Interventions

Type	Name	Description
DRUG	Venlafaxine 75 MG	Venlafaxine 75 mg extended release capsules for a 7-days duration
DRUG	Gabapentin 400 mg	Gabapentin 400 mg capsules

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2023-05-25
• Last updated: 2023-05-25

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study