NCT06091553招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-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.
排除标准
- •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,
研究组 & 干预措施
Duloxetine alone (as monotherapy)
Active Comparator
Duloxetine alone (as monotherapy)
干预措施: Duloxetine alone (Drug)
Duloxetine augmented with gabapentin (as combined therapy)
Active Comparator
Duloxetine augmented with gabapentin (as combined therapy)
干预措施: Duloxetine augmented with gabapentin (Drug)
Duloxetine augmented with amitriptyline (as combined therapy)
Active Comparator
Duloxetine augmented with amitriptyline (as combined therapy)
干预措施: Duloxetine augmented with amitriptyline (as combined therapy) (Drug)
结局指标
主要结局
The difference in numerical rating scale (NRS) daily pain measured during the final follow-up week (week 8) between the treatments.
时间窗: 8 week
次要结局
- Anxiety and depression Score(8 weeks)
- Quality of Life Score(8 week)
研究者
Hager salah el din
Principal Investigator
Beni-Suef University
研究点 (1)
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