Efficacy of N-acetylcysteine for the Prevention and Relief of Paclitaxel-induced Peripheral Neuropathy in Women With Ovarian, Tubal, and Peritoneal Cancer: an Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Paclitaxel-induce peripheral neuropathy
研究概览
简要总结
Ovarian cancer is third most common gynecologic cancer in Thai woman, treatment including surgery followed by chemotherapy.
Patient usually received paclitaxel every 3 week for 6 cycles, paclitaxel induce peripheral neuropathy is common dose dependent side effect which can disturb quality of life, result in chemotherapy dose reduction or discontinuation leading to poor prognosis and decreased survival Mechanism of PIPN including inflammation, promotion of microtubule polymerization and inhibition of depolymerization, and oxidative stress N-acetylcysteine is acetylated form of l-cysteine, might reduce oxidative stress. NAC can restore glutathione level, which is potent natural antioxidant. NAC might reduce PIPN
详细描述
This study was designed to evaluate the effect of NAC on the incidence and severity of PIPN in woman with ovarian, tubal, and peritoneal cancer who treated with paclitaxel for 3 cycles. (PIPPN is developed after cumulative doses 250 mg/m2 or more) Patient in controlled group, received Paclitaxel only. Patient in intervention group divided to two groups. First group received NAC 2400 mg/day for one week after received Paclitaxel each cycle for 3 cycles. Second group received NAC 2400 mg/day for 9 weeks Evaluate incidence and severity of PIPN before start CMT, and every visit after received CMT each cycle using Common Terminology Criteria for Adverse Event (CTCAE) ver.5, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and Patient Neurotoxicity Questionnaire (PNQ)
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patient aged 18 years old or more with ovarian, tubal, and peritoneal cancer who received Paclitaxel first course after surgery
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Normal laboratory testing
- •hemoglobin ≥10 g/dL, leukocyte count ≥ 3,000/mL, absolute neutrophil count ≥1,500/mL, platelet count ≥100,000/mL
- •Serum creatinine ≤1.5 mg/dL
- •Bilirubin ≤1.5 upper limit of normal
- •Alkaline phosphatase and serum glutamic oxaloacetate transaminase ≤3 upper limit of normal
排除标准
- •Patient with symptoms of peripheral neuropathy before study
- •Allergy to N-acetylcysteine
- •Psychiatric disorders
- •Pregnant woman
- •History of treated with other chemotherapy or radiotherapy before study
研究组 & 干预措施
NAC short course
patient received CMT(Paclitaxel) and NAC 2400 mg/day one week per each cycle of CMT
干预措施: N Acetylcysteine A (Drug)
NAC long course
patient received CMT(Paclitaxel) and NAC 2400 mg/day every day for 9 weeks
干预措施: N Acetylcysteine B (Drug)
结局指标
主要结局
Paclitaxel-induce peripheral neuropathy
时间窗: Day 0 (before chemotherapy administration), at the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days)
Assessment of grade of peripheral neuropathy by CTCAE v.5.0
次要结局
- Severity of paclitaxel-induce peripheral neuropathy(Day 0 (before chemotherapy administration), at the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days))
- Quality of life associated paclitaxel-induce peripheral neuropathy(Day 0 (before chemotherapy administration), at the end of cycle 1, at the end of cycle 2, and at the end of cycle 3 (each cycle is 21 days))