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Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial

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What is being tested

Duloxetine alone

+ Duloxetine augmented with gabapentin

+ Duloxetine augmented with amitriptyline (as combined therapy)

Drug
Who is being recruted

From 18 to 75 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsorBeni-Suef University
Study Contacthager salahMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 10, 2023

Actual date on which the first participant was enrolled.

This clinical trial focuses on finding the best way to treat chemotherapy-induced neuropathy, a common side effect that causes pain and discomfort in cancer patients undergoing chemotherapy. The study compares the effects of using the medication Duloxetine alone versus combining it with either Gabapentin or Amitriptyline. The goal is to determine which combination can most effectively relieve the symptoms of neuropathy while also being safe for patients. This research is important because it could lead to better pain management options for those dealing with the challenging side effects of cancer treatment. Participants in the study are divided into groups and given different treatments. One group receives Duloxetine alone, while the other groups receive Duloxetine combined with either Gabapentin or Amitriptyline. The medications are taken as prescribed by the healthcare provider, and their effects on neuropathy symptoms are closely monitored. The study evaluates how well each treatment eases the symptoms and checks for any side effects, aiming to identify the most effective and safest approach for managing chemotherapy-induced neuropathy.

Official TitleComparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial
NCT06091553
Principal SponsorBeni-Suef University
Study Contacthager salahMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Patients of any age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology.

Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;

Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;

Patients must received treatment with a chemotherapy regimen .

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10 exclusion criteria prevent from participating
History of allergic reactions attributed to compounds of similar chemical or biologic composition to duloxetine, amitriptyline and gabapentin

Pregnant women are excluded from this study.

Life expectancy less than 6 months

Inability or unwillingness to comply with research protocols.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Duloxetine alone (as monotherapy)

Group II

Active Comparator
Duloxetine augmented with gabapentin (as combined therapy)

Group III

Active Comparator
Duloxetine augmented with amitriptyline (as combined therapy)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Beni-Seuf University Hospital

Banī Suwayf, EgyptOpen Beni-Seuf University Hospital in Google Maps
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One Study Center