Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
研究概览
简要总结
This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits.
The only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment.
Preclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN.
TMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients who will receive paclitaxel.
- •Eastern Cooperative Oncology Group (ECOG) performance status from 0 to
- •Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl).
排除标准
- •Patients with signs and symptoms of clinical neuropathy at baseline.
- •Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
- •Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
- •Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
研究组 & 干预措施
Intervention
Trimetazidine Tablet 35 mg once daily for the treatment period
干预措施: Trimetazidine (Drug)
Control
Placebo once daily for the treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
时间窗: weekly for up to 8 weeks
Number of patients reported neuropathy from paclitaxel. a 1 to 5 graded scale; where grade (1) is the minimum value and grade (5) is the maximum value, a greater grades mean greater symptomatic burden.
Patient's Quality of Life
时间窗: at baseline, at the end of 4 weeks and at the end of 8 weeks
measures the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire. A total score ranging from 0 (minimum value) to 44 (maximum value), where lower scores mean greater symptomatic burden.
次要结局
- Severity of chemotherapy induced-peripheral neuropathy.(at baseline, at the end of 4 weeks and at the end of 8 weeks)
- Changes in serum levels of biomarker namely nerve growth factor (NGF).(at baseline and at end of 8 weeks)
- Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.(at baseline and weekly up to 8 week)
研究者
Asmaa Najm Iqbal Ahmed
Demonstrator
Minia University