Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Proportion of Patients Free from Nausea Throughout Treatment
研究概览
简要总结
This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.
详细描述
This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.
Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture.
Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications.
The study will evaluate primary and secondary outcomes, as well as monitor adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Patients aged 18 to 75 years, inclusive, from any nationality.
- •Patients diagnosed with early-stage breast cancer.
- •Eastern Cooperative Oncology Group performance status ranging from 0 to
- •All patients must undergo highly emetogenic chemotherapy (HEC).
- •Adequate organ function.
- •Adequate contraception required for premenopausal women.
排除标准
- •Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
- •Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle
- •Significant medical or psychological conditions.
- •Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
- •Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
- •Any known allergies to the study drug, antiemetics, or dexamethasone.
- •Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
- •Received acupuncture treatments for any conditions within 8 weeks prior to HEC.
研究组 & 干预措施
True Acupuncture Combined with Antiemetic Therapy
Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz.
干预措施: Electroacupuncture (Device)
True Acupuncture Combined with Antiemetic Therapy
Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz.
干预措施: Antiemetic Therapy (Drug)
Antiemetic therapy
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.
干预措施: Sham electroacupuncture (Device)
Antiemetic therapy
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.
干预措施: Antiemetic Therapy (Drug)
结局指标
主要结局
Proportion of Patients Free from Nausea Throughout Treatment
时间窗: 120 hours
The proportion of patients experiencing no nausea is determined by those who register a score of 0 on the visual-analogue scale for nausea throughout the entirety of treatment, spanning from initiation of chemotherapy to 120 hours post-treatment.
次要结局
未报告次要终点
研究者
Feixue Song
Professor
The Second Hospital of Lanzhou University