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.
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;
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;
Parallel
electroacupuncture
DeviceThe acupuncturist applied needles at four acupoints: Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6), with insertion depths of approximately 20 mm, 15 mm, 20 mm, and 5 mm respectively. Electrical stimulation was delivered in continuous wave mode at 2 Hz frequency with current intensity ≤10 mA (adjusted according to patient tolerance), administered for 30 minutes per session.
standard quadruple antiemetic therapy
DrugOlanzapine (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).
sham electroacupuncture
DeviceThe same acupoints as the electroacupuncture group were referenced, but with sham acupuncture (minimal insertion at non-acupoint locations) and sham electrical stimulation, while maintaining the same treatment duration and course as the electroacupuncture group.
standard quadruple antiemetic therapy
DrugOlanzapine (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). All the antiemetic drugs used are the same as those in the true acupuncture group.
The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.
Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy.
The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle.
The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle.
Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
Exploratory multi-omics analysis of electroacupuncture's modulation on symptom clusters.
Association between electroacupuncture and pathological complete response rate in patients receiving neoadjuvant therapy.
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Jiuda Zhao
Lead sponsor
Affiliated Hospital of Qinghai University
Sponsor institution
