The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy

Mendel AI60 enrolled

Overview

This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University. All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine. The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016). The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Oncology Pain Chemotherapy-induced Peripheral Neuropathy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. All patients, 18 years of age or older, with a cancer treated with Paclitaxel 2. Patients must have a life expectancy of at least 24 weeks. 3. Patients must sign an informed consent. 4. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry. 5. Patient matching high risk on the CIPN risk stratification scoring system Exclusion Criteria: 1. Patients with symptomatic brain metastases. 2. Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception. 3. Patients may receive no other concurrent complementary medicines during this study. 4. Patients with neuropathy induced diabetes. 5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections.

Outcomes

Primary Outcomes

Change in average daily pain intensity

Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF). Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain).

Time frame: 6 weeks

Electrophysiological studies

nerve conduction velocity at the end of the study