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
Duloxetine alone
+ Duloxetine augmented with gabapentin
+ Duloxetine augmented with amitriptyline (as combined therapy)
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy 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