Acupoint Application Combined With 5-HT3 Receptor Antagonist for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer Patients: A Single-Center, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete response rate of delayed-phase CINV (24-120 h)
研究概览
简要总结
This single-center, randomized, controlled study evaluates whether acupoint application added to standard 5-HT3 receptor antagonist anti-nausea medication improves control of chemotherapy-induced nausea and vomiting in adults with lung cancer receiving first-line platinum-based chemotherapy. Participants will be randomly assigned to receive either acupoint application plus a 5-HT3 receptor antagonist or the 5-HT3 receptor antagonist alone for one chemotherapy cycle. The study will compare complete control of delayed nausea and vomiting between the two groups.
详细描述
Adults with pathologically confirmed lung cancer who are scheduled to receive first-line platinum-based chemotherapy are eligible. After providing written informed consent, participants are randomized 1:1 to receive either acupoint application using a herbal plaster applied to selected acupoints plus standard 5-HT3 receptor antagonist prophylaxis, or 5-HT3 receptor antagonist prophylaxis alone. Nausea and vomiting episodes are recorded by participants using patient diaries, and quality of life is assessed with the Functional Living Index-Emesis questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Pathologically or cytologically confirmed lung cancer.
- •Scheduled to receive first-line platinum-based chemotherapy.
- •Aged 18 to 75 years.
- •Karnofsky Performance Status (KPS) score ≥
- •Expected survival ≥ 3 months.
- •Voluntarily signed written informed consent.
排除标准
- •Known allergy to any component of the acupoint plaster.
- •Severe skin disease, infection, or breakdown at the planned acupoint sites. --Pregnant or lactating women.
- •Cognitive impairment or psychiatric disorder that prevents completion of study assessments.
- •Participation in another interventional clinical trial within 30 days prior to enrollment.
研究组 & 干预措施
Acupoint application plus 5-HT3 receptor antagonist
Participants receive herbal acupoint plaster applied to selected acupoints plus standard 5-HT3 receptor antagonist prophylaxis before and during one cycle of platinum-based chemotherapy.
干预措施: 5-HT3 receptor antagonist (e.g., ondansetron) (Drug)
Acupoint application plus 5-HT3 receptor antagonist
Participants receive herbal acupoint plaster applied to selected acupoints plus standard 5-HT3 receptor antagonist prophylaxis before and during one cycle of platinum-based chemotherapy.
干预措施: Acupoint application (Other)
5-HT3 receptor antagonist alone
Participants receive standard 5-HT3 receptor antagonist prophylaxis alone before and during one cycle of platinum-based chemotherapy.
干预措施: 5-HT3 receptor antagonist (e.g., ondansetron) (Drug)
结局指标
主要结局
Complete response rate of delayed-phase CINV (24-120 h)
时间窗: 24 to 120 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days)
Complete response is defined as no emetic episodes and no rescue antiemetic use during 24 to 120 hours after the first cycle of platinum-based chemotherapy. The outcome will be compared between the acupoint application plus 5-HT3 receptor antagonist group and the 5-HT3 receptor antagonist alone group.
次要结局
- Complete response rate of acute-phase CINV (0-24 h)(0 to 24 hours after the first cycle of platinum-based chemotherapy (each cycle is 21-28 days))
- MAT nausea score(During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days))
- FLIE quality-of-life score(During the first cycle of platinum-based chemotherapy (each cycle is 21-28 days))
研究者
Xiu Huang
Associate Chief Physician, Department of Oncology
Chongqing Medical University