Fosaprepitant Combined With Tropisetron Plus Dexamethasone in Preventing Nausea and Emesis During Fractionated Radiotherapy With Weekly Cisplatin Chemotherapy in Cervical Cancer and Nasopharyngeal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- cumulative incidence of emesis overall phase
研究概览
简要总结
The study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south Chinese cohort.
详细描述
The study was designed as a prospective,randomized, single-blind control clinical trial aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or nasopharyngeal cancer.
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 (Participant)
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
- •histologically confirmed nasopharyngeal carcinoma (AJCC 8th stage II-IVa) or cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, clinical FIGO stage Ib2-IVa;), planning to receive concurrent chemoradiotherapy),18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
排除标准
- •took medications with antiemetic effect within 24 hours before initiation of concurrent chemoradiotherapy, had severe systemic diseases (such as uncontrolled diabetes/hypertension) or clinically unstable epileptic seizures require the use of anticonvulsants; allergic to fosaprepitant, tropisetron or dexamethasone.
研究组 & 干预措施
fosaprepitant group
Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
干预措施: Fosaprepitant (Drug)
fosaprepitant group
Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
干预措施: tropisetron (Drug)
fosaprepitant group
Intravenous fosaprepitant of 150mg was given before cisplatin administration on day 1. All patients received tropisetron 5mg and dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
干预措施: Dexamethasone (Drug)
control group
The control group was delivered tropisetron 5mg and dexamethasone 5mg only.
干预措施: tropisetron (Drug)
control group
The control group was delivered tropisetron 5mg and dexamethasone 5mg only.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
cumulative incidence of emesis overall phase
时间窗: 5 weeks
The primary endpoint of the study was the cumulative incidence of emesis overall phase (from 1st day of cycle 1 to 7th day of cycle 5, 7 days for one cycle).
次要结局
未报告次要终点
研究者
Chuangzhen Chen
Dr
Shantou University Medical College