A Randomized, Double-blind, Placebo-controlled Clinical Study on Prevention and Treatment of CINV Induced by TC Regimen in Gynecological Malignant Tumors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Complete response (CR) rate in the delayed period
研究概览
简要总结
To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.
Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Optimal prophylaxis is uncertain. This trial evaluated whether adding the NK1 receptor antagonist aprepitant to standard two-drug prophylaxis (5-HT3 receptor antagonist plus dexamethasone) improves CINV control.
详细描述
The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of TC in patients with gynecological malignant tumors High-level evidence-based medical evidence for programme-induced CINV. Therefore, different guidelines recommend the best antiemetic regimen as well It's different. This study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The designed Phase III clinical study provides important data and basis for clinical practice and guideline formulation.
In this prospective, multicenter, double-blind, placebo-controlled, crossover phase III trial, patients with gynecologic malignancies scheduled for at least two cycles of TC were randomly assigned to receive aprepitant or placebo with ondansetron and dexamethasone during cycle 1, crossing over to the alternate regimen in cycle 2. The primary endpoint was complete response (CR: no emesis, no significant nausea and no rescue therapy) in the delayed phase (24-168 hours). Secondary endpoints included CR in acute and overall phases, nausea severity, rescue medication use, adverse events, and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both patients and investigators, including follow-up staff, were blinded to treatment allocation.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A
patients in group A received the two-drug antiemetic regimen (placebo cycle) during the first cycle followed by the three-drug regimen (aprepitant cycle) during the second cycle.
The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.
The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime
干预措施: Aprepitant Injection (Drug)
Group B
patients in group B received the regimens in the reverse order. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime.
The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.
干预措施: Aprepitant Injection (Drug)
结局指标
主要结局
Complete response (CR) rate in the delayed period
时间窗: 24 hours to 7days after chemotherapy (each cycle is 21 days)
CR is defined as no emesis, no significant nausea (VAS ≤4, where 0 = none, 10= = most severe), and no use of rescue antiemetics.
次要结局
- CR rates in the acute phase (0-24 hours) and overall phase (0-7 days).(acute phase: within 24 hours after chemotherapy (each cycle is 21 days); overall phase: within 7 days after chemotherapy (each cycle is 21 days).)
- the use of rescue antiemetic(within 7 days after chemotherapy (each cycle is 21 days).)
- patient satisfaction(On day 7 and 14 of each cycle (each cycle is 21 days).)
- AEs(within 7 days after chemotherapy (each cycle is 21 days).)
- severity of nausea(within 7 days after chemotherapy (each cycle is 21 days).)
研究者
Dengfeng Wang
Deputy chief
Sichuan Cancer Hospital and Research Institute