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

Primary Purpose

Oncology Pain, Chemotherapy-induced Peripheral Neuropathy

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Venlafaxine
Memantine
Sponsored by
Mendel AI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oncology Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Venlafaxine Treated Arm

Memantine Treated Arm

Arm Description

Outcomes

Primary Outcome Measures

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).
Electrophysiological studies
nerve conduction velocity at the end of the study

Secondary Outcome Measures

Full Information

First Posted
January 30, 2021
Last Updated
January 30, 2021
Sponsor
Mendel AI
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04737967
Brief Title
The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
Official Title
The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Anticipated)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mendel AI
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology Pain, Chemotherapy-induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venlafaxine Treated Arm
Arm Type
Experimental
Arm Title
Memantine Treated Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Intervention Description
Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Patients will receive memantine (10 mg) once daily (Morel et al., 2016)
Primary Outcome Measure Information:
Title
Change in average daily pain intensity
Description
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
Title
Electrophysiological studies
Description
nerve conduction velocity at the end of the study
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gehad Sayed Ahmed, MD
Phone
+201222352664
Email
Gehad.S.Fadl@kasralainy.edu.eg
Facility Information:
Facility Name
Faculty of Medicine Cairo University - Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gehad Sayed Ahmed, MD
Phone
+201222352664
Email
Gehad.S.Fadl@kasralainy.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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