Personalized Electroacupuncture Treatment Combined With Standard Antiemetic Drugs for Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer Receiving Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Significant Nausea, Rescue Treatment and Number of Times of Vomiting Occurs After chemotherapy (complete protection).
研究概览
简要总结
This study aims to evaluate electroacupuncture as an antiemetic treatment compared with sham acupuncture in patients with breast cancer, receiving highly emetogenic chemotherapy (HEC). Moreover, it will analyze the association between single nucleotide polymorphism and the antiemetic outcomes of electroacupuncture.
详细描述
This is a parallel-group, triple-blinded (participants, evaluators and statisticians), randomized controlled study that investigates the antiemetic role of electroacupuncture combined with standard antiemetic drugs for patients with breast cancer receiving HEC. Neurokinin-1 receptor antagonists (NK-1RAs), serotonin receptor antagonists [5HT3RA] and dexamethasone will be administered prior to initiation of HEC on Day 1 in both groups. Electroacupuncture or sham acupuncture will be randomly administered to the two groups. Subjects will record all events of emesis and the use of rescue antiemetic medication for nausea and/or vomiting. Blood samples will be collected and be analyzed to whether genetic polymorphisms can be used to predict Electroacupuncture outcomes in patients with breast cancer receiving HEC. Primary and secondary outcomes and adverse events will be evaluated.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older, of any nationality;
- •Eastern Cooperative Oncology Group performance status of 0-2;
- •For patients with breast cancer, molecular typing is not limited, receiving for the first time chemotherapy with anthracyclines+ cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin -based HEC regimen. Patients with previous chemotherapy use could be enrolled if they received it >3 months;
- •Predicted life expectancy of ≥3 months;
- •Adequate bone marrow, kidney, and liver function;
- •Adequate contraception if premenopausal women;
- •Written informed consent by the patient before enrolment.
排除标准
- •Patients already submitted to chemotherapy;
- •Is scheduled to receive any non-HEC on Day 1;
- •Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;
- •Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
- •Have ongoing emesis or CTCAE grade 2 or greater nausea;
- •Significant mental conditions;
- •Any allergies to study drug, antiemetics or dexamethasone;
- •Significantly abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine);
- •Patients who are pregnant or breast-feeding;
- •Inflammatory skin reaction;
- •Has lymphedema in acupuncture stimulation area;
- •Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
- •Received acupuncture treatments for any conditions less than 4 weeks before HEC;
- •The current use of any drugs with antiemetic activity (e.g. 5-HT3 RA, dopamine receptor antagonist, minor tranquilizer, antihistamine);
- •Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, hypercalcemia and symptomatic brain metastasis;
- •Patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy;
- •Patients receiving concomitant steroids, except when administered at physiologic doses;
- •Patients receiving concomitant benzodiazepines, except when used for nocturnal sedation.
结局指标
主要结局
Proportion of Patients With Significant Nausea, Rescue Treatment and Number of Times of Vomiting Occurs After chemotherapy (complete protection).
时间窗: 120 hours
The proportion of patients achieving complete protection is defined as patients who have no vomiting, no rescue treatment, no significant nausea that was assessed by visual analog scale (VAS, this is a Visual Analogue Scale was used to assess the incidence and intensity of nausea daily, a 100-mm horizontal bar containing no marking except for the anchor point at each end: left, no nausea; right, worst nausea. No nausea was defined as a VAS scores \< 5mm, no significant nausea was defined as a VAS scores \< 25mm), and maximum less than 25 mm during the first 120 hours after the initiation of chemotherapy (The definition is different from the complete response in the "Secondary endpoints" section).
次要结局
- Fatigue(120 hours)
- Number of times of no vomiting in the overall stage (0 to 120 hours) after chemotherapy (no vomiting in the overall stage)(120 hours)
- The proportion of no significant nausea (no significant nausea in the overall stage)(120 hours)
- Diarrhea(120 hours)
- The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 24 to 120 hours (delayed complete response)(120 hours)
- Number of times of no vomiting in the acute stage (0 to 24 hours) after chemotherapy (no vomiting in the acute stage)(24 hours)
- Constipation(120 hours)
- The relationship between single nucleotide polymorphism genotypes and the proportion of patients with significant nausea, rescue treatment and number of times of vomiting occurs after chemotherapy (complete protection).(120 hours)
- The proportion of patients who have no vomiting/retching or rescue medications after chemotherapy during 0 to 24 hours (acute complete response)(24 hours)
- Number of times of no vomiting in the delayed stage (24 to 120 hours) after chemotherapy (no vomiting in the delayed stage)(120 hours)
- The proportion of no nausea (no nausea in the overall stage)(120 hours)
- Insomnia(120 hours)
- The proportion of patients achieving total control (total control in the overall stage)(120 hours)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University