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

Phase 2

• Conditions: Chemotherapy-induced Peripheral Neuropathy; Oncology Pain
• Interventions: Drug: Memantine; Drug: Venlafaxine

• Registration Number: NCT04737967
• Lead Sponsor: Mendel AI

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-30
• Study First Submitted QC: 2021-01-30
• Last Update Submitted: 2021-01-30
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04
• Study Start: 2021-02-15
• Primary Completion: 2021-08-15
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Memantine Treated Arm	Memantine	-
Venlafaxine Treated Arm	Venlafaxine	-

Primary Outcome Measures

Name	Time	Method
Change in average daily pain intensity	6 weeks	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).
Electrophysiological studies	6 weeks	nerve conduction velocity at the end of the study

Trial Locations

Locations (1)

Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine; 🇪🇬 Cairo, Egypt