Clinical trial NCT06091553: Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuropathy in Cacer Patien
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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,

Primary outcomes:
measure: The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.
timeFrame: 8 week
Secondary outcomes:
measure: Quality of Life Score
timeFrame: 8 week
measure: Anxiety and depression Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Seuf University Hospital
Study officials:
References: