A Study on Electroacupuncture Combined With Olanzapine-contained Four-drug Antiemetic Therapy for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer (ECO 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 with no nausea during the overall stage
研究概览
简要总结
This randomized controlled phase III trial aims to evaluate the use of electroacupuncture in combination with olanzapine-containing standard quadruple antiemetic drugs for the treatment of nausea and vomiting induced by highly emetogenic chemotherapy (HEC) in patients with breast cancer. Furthermore, it will analyze the relationship between single nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea and vomiting.
详细描述
This study is a parallel-group, blinded (participants, evaluators, and statisticians), randomized controlled trial exploring the effectiveness of electroacupuncture combined with standard quadruple antiemetic drugs for breast cancer patients undergoing HEC. Both groups will receive Olanzapine, Neurokinin-1 receptor antagonists (NK-1RAs), serotonin receptor antagonists [5HT3RA], and dexamethasone at the start of HEC on Day 1. Electroacupuncture or sham acupuncture will be randomly administered to each group. Participants will document all instances of nausea and vomiting and note the use of rescue antiemetic medications. Blood samples will be collected and analyzed to investigate whether genetic polymorphisms can predict electroacupuncture outcomes in breast cancer patients undergoing HEC. Primary and secondary outcomes as well as adverse events will be assessed.
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
- •Aged 18 years or older and aged 75 years or younger, of any nationality;
- •Eastern Cooperative Oncology Group performance status of 0-2;
- •Patients with breast cancer, with no restrictions on molecular typing; early-stage patients must not have undergone prior chemotherapy, while advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin;
- •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;
- •Is scheduled to receive any chemotherapy on days 2-4 after HEC;
- •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 medical or mental conditions;
- •Any allergies to study drug, antiemetics or dexamethasone;
- •Significantly abnormal laboratory values (platelets, coagulation indexes, 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;
- •Currently using drugs with antiemetic activity (e.g., 5-HT3 receptor antagonists, corticosteroids (except when used at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nocturnal sedation));
- •Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;
- •Has a convulsive disorder requiring anticonvulsant treatment;
- •Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);
- •Concurrent treatment with quinolone antibiotics;
- •Has a history of chronic alcoholism (determined by the investigator);
- •Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;
- •Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).
研究组 & 干预措施
True acupuncture + standard quadruple antiemetic therapy
Participants will receive electroacupuncture once daily from day 1 to day 4. The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz. They will receive olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.
干预措施: Electroacupuncture (Device)
True acupuncture + standard quadruple antiemetic therapy
Participants will receive electroacupuncture once daily from day 1 to day 4. The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz. They will receive olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.
干预措施: Standard antiemetic treatment (Drug)
Sham acupuncture + standard quadruple antiemetic therapy
The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group.Care was taken to avoid "de qi" sensation. They will receive olanzapine-contained four-drug antiemetic therapy. All the antiemetic drugs used are the same as those in the true acupuncture group.
干预措施: Sham electroacupuncture (Device)
Sham acupuncture + standard quadruple antiemetic therapy
The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group.Care was taken to avoid "de qi" sensation. They will receive olanzapine-contained four-drug antiemetic therapy. All the antiemetic drugs used are the same as those in the true acupuncture group.
干预措施: Standard antiemetic treatment (Drug)
结局指标
主要结局
Proportion of patients with no nausea during the overall stage
时间窗: 120 hours
The proportion of patients achieving no nausea is defined as patients who have a response of 0 on the Visual Analog Scale for nausea during the overall stage (0 to 120 hours) after the initiation of chemotherapy.
次要结局
- Proportion of patients with no nausea during the delayed stage(96 hours)
- The proportion of patients achieving total control in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours).(120 hours)
- Proportion of patients with no nausea during the early stage(24 hours)
- Fatigue(120 hours)
- The relationship between single nucleotide polymorphism genotypes and the proportion of patients with no nausea(120 hours)
- The proportion of patients achieving complete protection in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)(120 hours)
- The proportion of no significant nausea in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)(120 hours)
- The proportion of no nausea (Visual Analog Scale score < 5) in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)(120 hours)
- The side effects of electroacupuncture treatment(120 hours)
- The proportion of patients achieving complete response in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)(120 hours)
- Quality of life in the overall stage(120 hours)
- Insomnia(120 hours)
- Constipation(120 hours)
研究者
Jiuda Zhao
Breast Disease Diagnosis and Treatment Center
Affiliated Hospital of Qinghai University