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

Study Overview
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Brief Summary
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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)

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

Conditions
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Oncology Pain, Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Drug: Venlafaxine
* Drug: Memantine


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venlafaxine Treated Arm<br> | Drug: Venlafaxine<br>* Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)<br>|
| Experimental: Memantine Treated Arm<br> | Drug: Memantine<br>* Patients will receive memantine (10 mg) once daily (Morel et al., 2016)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 weeks | 
| Electrophysiological studies | nerve conduction velocity at the end of the study | 6 weeks |