A Phase III Randomized Controlled Trial of Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 374
- 主要终点
- Complete Response (CR) Rate of CINV within 0-120 hours
研究概览
简要总结
This phase III, multicenter, randomized, open-label trial evaluates whether aromatherapy plus standard antiemetic therapy improves complete response (CR) of CINV compared with standard therapy alone in breast cancer patients receiving highly emetogenic chemotherapy (HEC). Despite guideline-recommended triple prophylaxis (5-HT3 antagonist, NK-1 antagonist, dexamethasone), 30-50% of patients still develop delayed CINV. Aromatherapy with lemon, lavender, and peppermint essential oils may provide additive benefit through olfactory-limbic and vagal pathways, but phase III evidence is lacking. 374 patients (aged 18-80) scheduled for at least two HEC cycles will be randomized 1:1, stratified by prior CINV. On chemo day, aromatherapy starts 30 min before and continues until 2 h after chemotherapy; on days 2-5, inhalation is at least 2 h daily.Primary endpoint: complete response (no vomiting, no rescue antiemetic) over 0-120 h. Key secondary endpoints: acute and delayed CR rates, complete/total control rates, time to treatment failure, quality of life (FLIE), anxiety, depression, sleep quality, and safety. Exploratory: plasma GDF15 dynamics and predictive value.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed breast cancer (aged 18-80 years, inclusive).
- •Scheduled to receive or currently receiving intravenous chemotherapy, with at least 2 planned cycles.
- •Planned use of guideline-recommended triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).
- •ECOG performance status ≤ 2 and life expectancy ≥ 3 months.
- •Chemotherapy regimen classified as highly emetogenic risk according to CSCO, NCCN, or MASCC/ESMO antiemetic guidelines.
- •Able to understand the study procedures, voluntarily participate, and provide written informed consent.
排除标准
- •History of allergy to essential oils.
- •History of vestibular dysfunction or intestinal obstruction.
- •Major cardiovascular or cerebrovascular event within the past 12 months (e.g., unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction; asymptomatic lacunar infarction not requiring treatment is allowed).
- •Pregnancy, lactation, or possibility of pregnancy without willingness to use contraception.
- •History or current diagnosis of significant neurological or psychiatric disorders, including epilepsy or dementia.
- •Poor compliance anticipated, or any other condition that the investigator considers inappropriate for participation.
研究组 & 干预措施
Experimental Arm: Aromatherapy + Standard Antiemetic Therapy
Patients receive aromatherapy with standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).
干预措施: Aromatherapy (Other)
Experimental Arm: Aromatherapy + Standard Antiemetic Therapy
Patients receive aromatherapy with standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone).
干预措施: Standard triple antiemetic therapy (Drug)
Control Arm: Standard Antiemetic Therapy Alone
Patients receive standard triple antiemetic therapy (5-HT3 receptor antagonist + NK-1 receptor antagonist + dexamethasone) .
干预措施: Standard triple antiemetic therapy (Drug)
结局指标
主要结局
Complete Response (CR) Rate of CINV within 0-120 hours
时间窗: 0-120 hours after chemotherapy (Day 1 to Day 5)
次要结局
- CR Rate in Acute Phase (0-24 hours)((0-24 hours))
- CR Rate in Delayed Phase (25-120 hours)(25-120 hours)
- Complete Control (CC) Rate(0-120 hours)
- Total Control (TC) Rate(0-120 hours)
- Time to Treatment Failure (TTF)(0-120 hours)