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

Inclusion Criteria:

• -Patients of any age must have histologically or cytologically confirmed cancer by theLaboratory of Pathology.
• Patients must sign an informed consent form (ICF) voluntarily and be able tounderstand 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 theinformed 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 biologiccomposition 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 asdiabetes.
• The presence of mental illness, epilepsy, mania, suicidal depression, dementia oralcohol 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) NewYork Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstableangina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 monthsprior to first dose; (4) atrial fibrillation and supraventricular or ventriculararrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cavasyndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7)hypertensive disease not controlled by antihypertensive medication: systolic bloodpressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
• Patients with other medical history or evidence of disease that has the potential toconfound trial results are excluded from the study,