Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy

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

This study aimed to elucidate the relationship between the Efficacy and Safety of Comparison of the Efficacy and Safety Duloxetine augmented with gabapentin and amitriptyline augmented with Duloxetine vs duloxetine alone in chemotherapy -Induced Neuropathy in cancer patients.

Study Overview

• Status: Recruiting
• Conditions: Neuropathy in Cacer Patien
• Intervention / Treatment: Drug: Duloxetine alone; Drug: Duloxetine augmented with gabapentin; Drug: Duloxetine augmented with amitriptyline (as combined therapy)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: hager salah; Phone Number: 0097336679556; Email: hager.salah@rocketmail.com
• Study Contact Backup: Name: ahmed hassan; Phone Number: 01061246789; Email: ahmedhassan_dr@yahoo.com

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Recruiting
    • Beni-Seuf University Hospital
    • Contact: ahmed H shaaban, MD; Phone Number: 0201061246789; Email: ahmedhasan_dr@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• -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 .
• Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
• Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2;
• Expected survival of ≥ 3 months
• There is no maximum number of prior medical therapies.

Exclusion Criteria:

• 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.
• Patients with the presence of active brain or meningeal metastases.
• Patients with the presence of uncontrolled closed-angle glaucoma.
• Patients with the presence of neuropathy caused by any type of nerve compression as diabetes.
• The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements.
• The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
• Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Active Comparator: Duloxetine alone (as monotherapy)	Drug: Duloxetine alone; 30 mg once daily for 1 week, then 60 mg once daily
Active Comparator: Duloxetine augmented with gabapentin (as combined therapy)	Drug: Duloxetine augmented with gabapentin; 30 mg once daily for 1 week, then 60 mg once daily 300 mg at bedtime
Active Comparator: Duloxetine augmented with amitriptyline (as combined therapy)	Drug: Duloxetine augmented with amitriptyline (as combined therapy); 10 to 25 mg once daily at bedtime 30 mg once daily for 1 week, then 60 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.	8 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Score	8 week
Anxiety and depression Score	8 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Anti-Anxiety Agents; Anticonvulsants; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Tricyclic; Antimanic Agents; Adrenergic Uptake Inhibitors; Duloxetine Hydrochloride; Gabapentin; Amitriptyline
• Other Study ID Numbers: IORG0006240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No