Comparing Duloxetine with Gabapentin and Amitriptyline for Chemotherapy-Induced Neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of Duloxetine augmented with Gabapentin and Duloxetine augmented with Amitriptyline compared to Duloxetine alone in treating chemotherapy-induced neuropathy in cancer patients. It involves patients aged 18 to 75 who have confirmed cancer and experience significant neuropathy symptoms. The study aims to determine which combination therapy provides better relief from neuropathic pain associated with chemotherapy.

Why it matters

Who can join: the full rules

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,

Where it's running

• Beni-Seuf University Hospital
  Banī Suwayf, Egypt Recruiting

Study contacts

• Study coordinator: hager salah
• Email: hager.salah@rocketmail.com
• Phone: 0097336679556

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.