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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737967
• Other study ID #: CIPN101
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 15, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2021
• Source: Mendel AI
• Contact: Gehad Sayed Ahmed, MD
• Phone: +201222352664
• Email: Gehad.S.Fadl[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Chemotherapy-induced Peripheral Neuropathy
• Oncology Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• Venlafaxine
Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)
• Memantine
Patients will receive memantine (10 mg) once daily (Morel et al., 2016)

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Mendel AI	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Electrophysiological studies	nerve conduction velocity at the end of the study	6 weeks