Preventive Approach Using Venlafaxine

Peripheral Neuropathy Due to Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875610
• Other study ID #: 1
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Mit Ghamr Oncology Center
• Contact: Mahmoud Mahrous
• Phone: +201007778360
• Email: mahmodmahros71[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients >24 years of age, men or women to lower risk of suicidal tendency.
• Patients with histologically proven cancer
• Patients receiving oxaliplatin or taxanes-based regimen
• WHO performance status of 0-2
• serum AST or ALT no higher than two times the upper limit of normal
• serum creatinine level less than 2 mg/dL
• platelet count of at least 100,000/mm3
• absolute neutrophil count of at least to 1.0 G/L
• Female patients, those with a negative urine pregnancy test.

Exclusion Criteria:

• Patients with brain or leptomeningeal metastasis.
• Patients with previous platinum-based chemotherapy
• Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions.
• Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy Due to Chemotherapy

Intervention

Drug:
• Venlafaxine 75 MG
Venlafaxine 75 mg extended release capsules for a 7-days duration
• Gabapentin 400 mg
Gabapentin 400 mg capsules

Locations

Country	Name	City	State
Egypt	Mit Ghamr Oncology Center	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mit Ghamr Oncology Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of grade II or more peripheral neuropathy	Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)	4 months
Secondary	The EORTC QLQ-CIPN20 subscales	Sensory subscale, motor, and autonomic subscales of CIPN20	4 months
Secondary	Pain Severity	The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)	4 months