Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.
研究概览
简要总结
This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify the key targets of electroacupuncture intervention, thereby providing high-level evidence-based medical support and theoretical foundations for optimizing electroacupuncture strategies in addressing chemotherapy-induced gastrointestinal symptoms in patients with cancer.
详细描述
This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + dexamethasone + 5-HT3 receptor antagonist + NK-1 receptor antagonist) versus sham EA plus identical antiemetic regimen for chemotherapy-induced gastrointestinal symptom clusters (nausea, vomiting, poor appetite, and xerostomia ). The EA group receives true acupuncture with continuous wave stimulation (2Hz frequency, ≤10mA intensity as tolerated, 30min/session) administered: (1) 1-2h pre-chemotherapy on Day 1, and (2) daily at 9:00-10:00 from Days 2-4. Controls receive sham EA with an identical treatment schedule and the same antiemetics. Assessments during Days 1-5 include: Researchers record the incidence of nausea, vomiting, poor appetite, and xerostomia; Collection of weight, ECOG scores, and EQ-5D-5L questionnaires; documentation of antiemetic/chemotherapy use, concomitant medications, and adverse events; laboratory tests per cycle; and imaging when indicated. Blood samples are preserved every two cycles. Primary/secondary outcomes and adverse events are systematically evaluated.
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
- 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
- 否
入选标准
- •Radiologically and pathologically confirmed stage I-III breast cancer;
- •An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- •Age between 18 and 75 years;
- •Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy;
- •No prior acupuncture treatment within one month before enrollment;
- •Voluntary participation in the study with written informed consent obtained; (7) An expected survival of at least 3 months;
- •(8) Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria.
排除标准
- •Patients with advanced-stage cancer;
- •Those undergoing concurrent chemoradiotherapy;
- •Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
- •Patients with contraindications to acupuncture, such as active skin infections;
- •Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
- •Patients with a history of xerostomia;
- •Individuals with known allergies to the study drugs;
- •Pregnant or breastfeeding patients;
- •Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation);
- •Patients with seizure disorders requiring anticonvulsant therapy;
- •Those receiving thiazides as chronic antipsychotic medications;
- •Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
研究组 & 干预措施
true acupuncture + standard quadruple antiemetic therapy
The experimental group received electroacupuncture (EA) combined with a standard quadruple antiemetic regimen comprising Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). EA was applied at Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6) with insertion depths of 20 mm, 15 mm, 20 mm, and 5 mm respectively, using continuous wave mode at 2 Hz and current intensity ≤10 mA (tolerance-adjusted) for 30 minutes per session. Treatment started 1-2 hours pre-chemotherapy on day 1 and continued daily at 9:00-10:00 on days 2-4, totaling four sessions per cycle.
干预措施: electroacupuncture (Device)
true acupuncture + standard quadruple antiemetic therapy
The experimental group received electroacupuncture (EA) combined with a standard quadruple antiemetic regimen comprising Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). EA was applied at Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6) with insertion depths of 20 mm, 15 mm, 20 mm, and 5 mm respectively, using continuous wave mode at 2 Hz and current intensity ≤10 mA (tolerance-adjusted) for 30 minutes per session. Treatment started 1-2 hours pre-chemotherapy on day 1 and continued daily at 9:00-10:00 on days 2-4, totaling four sessions per cycle.
干预措施: standard quadruple antiemetic therapy (Drug)
sham acupuncture + standard quadruple antiemetic therapy
The control group received sham electroacupuncture combined with the identical standard quadruple antiemetic regimen (drug components and dosages identical to the experimental group). The sham intervention protocol consisted of: (1) superficial needle insertion at non-acupoint locations adjacent to the authentic acupoints (ST36, PC6, LI4, and KI6); (2) attachment of non-functional electrodes using deactivated electroacupuncture devices with identical appearance to active units; while maintaining identical treatment duration (30 minutes/session) and schedule (pre-chemotherapy on day 1 followed by daily sessions on days 2-4) as the true electroacupuncture group.
干预措施: sham electroacupuncture (Device)
sham acupuncture + standard quadruple antiemetic therapy
The control group received sham electroacupuncture combined with the identical standard quadruple antiemetic regimen (drug components and dosages identical to the experimental group). The sham intervention protocol consisted of: (1) superficial needle insertion at non-acupoint locations adjacent to the authentic acupoints (ST36, PC6, LI4, and KI6); (2) attachment of non-functional electrodes using deactivated electroacupuncture devices with identical appearance to active units; while maintaining identical treatment duration (30 minutes/session) and schedule (pre-chemotherapy on day 1 followed by daily sessions on days 2-4) as the true electroacupuncture group.
干预措施: standard quadruple antiemetic therapy (Drug)
结局指标
主要结局
The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.
时间窗: 120 hours
次要结局
- Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy.(120 hours)
- The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle.(120 hours)
- The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle.(120 hours)
- Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle.(120 hours)
- Complete protection rates in the overall, acute, and delayed phases following the first chemotherapy cycle.(120 hours)
- Quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L).(120 hours)
研究者
Jiuda Zhao
Clinical Professor
Affiliated Hospital of Qinghai University