Preventive Approach Using Venlafaxine

Phase 4

Recruiting

• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Interventions: Drug: Venlafaxine 75 MG; Drug: Gabapentin 400 mg

• Registration Number: NCT05875610
• Lead Sponsor: Mit Ghamr Oncology Center

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 (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 Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-01
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venlafaxine Arm	Venlafaxine 75 MG	Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.
Gabapentin Arm	Gabapentin 400 mg	Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Primary Outcome Measures

Name	Time	Method
The incidence of grade II or more peripheral neuropathy	4 months	Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)

Secondary Outcome Measures

Name	Time	Method
The EORTC QLQ-CIPN20 subscales	4 months	Sensory subscale, motor, and autonomic subscales of CIPN20
Pain Severity	4 months	The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)

Trial Locations

Locations (1)

Mit Ghamr Oncology Center; 🇪🇬 Mansoura, Dakahlia, Egypt