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

Beni-Suef University

Status and phase: Enrolling; Phase 2

Conditions: Neuropathy in Cacer Patien

Treatments: Drug: Duloxetine augmented with amitriptyline (as combined therapy); Drug: Duloxetine augmented with gabapentin; Drug: Duloxetine alone

Study type: Interventional

Funder types: Other

Identifiers

NCT06091553

IORG0006240

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Duloxetine alone (as monotherapy)

Active Comparator group

Description:

Duloxetine alone (as monotherapy)

Treatment:

Drug: Duloxetine alone

Duloxetine augmented with gabapentin (as combined therapy)

Active Comparator group

Description:

Duloxetine augmented with gabapentin (as combined therapy)

Treatment:

Drug: Duloxetine augmented with gabapentin

Duloxetine augmented with amitriptyline (as combined therapy)

Active Comparator group

Description:

Duloxetine augmented with amitriptyline (as combined therapy)

Treatment:

Drug: Duloxetine augmented with amitriptyline (as combined therapy)

control

No Intervention group

Description:

control