Preventive Approach Using Venlafaxine

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Intervention / Treatment: Drug: Venlafaxine 75 MG; Drug: Gabapentin 400 mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mahmoud Mahrous; Phone Number: +201007778360; Email: mahmodmahros71@gmail.com

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt
      • Recruiting
      • Mit Ghamr Oncology Center
      • Contact: Mahmoud A Mahrous; Phone Number: +201007778360; Email: mahmodmahros71@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venlafaxine Arm; Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.	Drug: Venlafaxine 75 MG; Venlafaxine 75 mg extended release capsules for a 7-days duration
Active Comparator: Gabapentin Arm; Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.	Drug: Gabapentin 400 mg; Gabapentin 400 mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The EORTC QLQ-CIPN20 subscales	Sensory subscale, motor, and autonomic subscales of CIPN20	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)	4 months

Collaborators and Investigators

• Sponsor: Mit Ghamr Oncology Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: oxaliplatin; Chemotherapy; Venlafaxine; Peripheral neuropathy; Taxanes
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Anti-Anxiety Agents; Anticonvulsants; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Antimanic Agents; Gabapentin; Venlafaxine Hydrochloride
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes