Comparing Duloxetine with Gabapentin and Amitriptyline for 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 is testing whether adding Gabapentin or Amitriptyline to Duloxetine can help cancer patients with chemotherapy-induced nerve pain feel better than using Duloxetine alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beni-Suef University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Banī Suwayf) |
| Trial ID | NCT06091553 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are cancer patients aged 18 to 75 with confirmed diagnoses and significant chemotherapy-induced peripheral neuropathy.
Not a fit: Patients with a history of allergic reactions to Duloxetine, Gabapentin, or Amitriptyline may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer improved pain management options for cancer patients suffering from chemotherapy-induced neuropathy.
How similar studies have performed: Other studies have explored similar combination therapies for neuropathic pain, showing promising results, but this specific approach is less common.
Eligibility criteria
Show full inclusion / exclusion 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,
Where this trial is running
Banī Suwayf
- Beni-Seuf University Hospital — Banī Suwayf, Egypt (Recruiting)
Study contacts
- Study coordinator: hager salah
- Email: hager.salah@rocketmail.com
- Phone: 0097336679556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.