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Preventive Approach Using Venlafaxine

Primary Purpose

Peripheral Neuropathy Due to Chemotherapy

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Venlafaxine 75 MG
Gabapentin 400 mg
Sponsored by
Mit Ghamr Oncology Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy Due to Chemotherapy focused on measuring Peripheral neuropathy, Taxanes, oxaliplatin, Chemotherapy, Venlafaxine

Eligibility Criteria

24 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients >24 years of age, men or women to lower risk of suicidal tendency. Patients with histologically proven cancer Patients receiving oxaliplatin or taxanes-based regimen WHO performance status of 0-2 serum AST or ALT no higher than two times the upper limit of normal serum creatinine level less than 2 mg/dL platelet count of at least 100,000/mm3 absolute neutrophil count of at least to 1.0 G/L Female patients, those with a negative urine pregnancy test. Exclusion Criteria: Patients with brain or leptomeningeal metastasis. Patients with previous platinum-based chemotherapy Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions. Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.

Sites / Locations

  • Mit Ghamr Oncology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Venlafaxine Arm

Gabapentin Arm

Arm Description

Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.

Outcomes

Primary Outcome Measures

The incidence of grade II or more peripheral neuropathy
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)

Secondary Outcome Measures

The EORTC QLQ-CIPN20 subscales
Sensory subscale, motor, and autonomic subscales of CIPN20
Pain Severity
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Mit Ghamr Oncology Center
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1. Study Identification

Unique Protocol Identification Number
NCT05875610
Brief Title
Preventive Approach Using Venlafaxine
Official Title
Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mit Ghamr Oncology Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.
Detailed Description
Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders. A wide range of neurologic complications can associate antineoplastic drug treatment. Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity. Moreover, taxanes (paclitaxel) are also associated with neurotoxicity. In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine (37.5 mg extended release twice daily from day 2 to 11) or placebo, however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice, until additional supporting data become available. patients will be randomly assigned to treatment arms: Arm A: to receive venlafaxine hydrochloride 75 mg (Effexor X.R) 75mg once daily from day 1 to day 7 to avoid need of dose tapering . Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy Due to Chemotherapy
Keywords
Peripheral neuropathy, Taxanes, oxaliplatin, Chemotherapy, Venlafaxine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venlafaxine Arm
Arm Type
Experimental
Arm Description
Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.
Arm Title
Gabapentin Arm
Arm Type
Active Comparator
Arm Description
Patients receiving Taxanes (Docetaxel or Paclitaxel) or Oxaliplatin containing regimens.
Intervention Type
Drug
Intervention Name(s)
Venlafaxine 75 MG
Intervention Description
Venlafaxine 75 mg extended release capsules for a 7-days duration
Intervention Type
Drug
Intervention Name(s)
Gabapentin 400 mg
Intervention Description
Gabapentin 400 mg capsules
Primary Outcome Measure Information:
Title
The incidence of grade II or more peripheral neuropathy
Description
Grading of chemotherapy induced peripheral neuropathy will be done using NCI-CTCAE version (5)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The EORTC QLQ-CIPN20 subscales
Description
Sensory subscale, motor, and autonomic subscales of CIPN20
Time Frame
4 months
Title
Pain Severity
Description
The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients >24 years of age, men or women to lower risk of suicidal tendency. Patients with histologically proven cancer Patients receiving oxaliplatin or taxanes-based regimen WHO performance status of 0-2 serum AST or ALT no higher than two times the upper limit of normal serum creatinine level less than 2 mg/dL platelet count of at least 100,000/mm3 absolute neutrophil count of at least to 1.0 G/L Female patients, those with a negative urine pregnancy test. Exclusion Criteria: Patients with brain or leptomeningeal metastasis. Patients with previous platinum-based chemotherapy Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions. Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Mahrous
Phone
+201007778360
Email
mahmodmahros71@gmail.com
Facility Information:
Facility Name
Mit Ghamr Oncology Center
City
Mansoura
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud A Mahrous
Phone
+201007778360
Email
mahmodmahros71@gmail.com

12. IPD Sharing Statement

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Preventive Approach Using Venlafaxine

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