Clinical trial NCT06952920: Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer
Official title: Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Standard Quadruple Antiemetic Therapy
Electroacupuncture
Chemotherapy-induced Gastrointestinal Symptom Cluster
Keywords: breast cancer
chemotherapy
standard quadruple antiemetic therapy
electroacupuncture
chemotherapy-induced gastrointestinal symptom cluster
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed stage I-III breast cancer;
2. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
3. Age between 18 and 75 years;
4. Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy;
5. No prior acupuncture treatment within one month before enrollment;
6. 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.

Exclusion Criteria:

1. Patients with advanced-stage cancer;
2. Those undergoing concurrent chemoradiotherapy;
3. Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
4. Patients with contraindications to acupuncture, such as active skin infections;
5. Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
6. Patients with a history of xerostomia;
7. Individuals with known allergies to the study drugs;
8. Pregnant or breastfeeding patients;
9. 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);
10. Patients with seizure disorders requiring anticonvulsant therapy;
11. Those receiving thiazides as chronic antipsychotic medications;
12. Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.

Primary outcomes:
measure: The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.
timeFrame: 120 hours
Secondary outcomes:
measure: Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy.
timeFrame: 120 hours
measure: The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle.
timeFrame: 120 hours
measure: The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle.
timeFrame: 120 hours
measure: Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
timeFrame: 120 hours
measure: Complete protection rates in the overall, acute, and delayed phases following the first chemotherapy cycle.
timeFrame: 120 hours
measure: Quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L).
timeFrame: 120 hours
Other outcomes:
measure: Exploratory multi-omics analysis of electroacupuncture's modulation on symptom clusters.
timeFrame: From enrollment through the entire chemotherapy cycle (up to 8 cycles, each cycle is 21 days; maximum 64 weeks)
measure: Association between electroacupuncture and pathological complete response rate in patients receiving neoadjuvant therapy.
timeFrame: From enrollment through the entire chemotherapy cycle From enrollment through the entire chemotherapy cycle (up to 8 cycles, each cycle is 21 days; maximum 64 weeks)
Locations:
city: XiNing
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
Study officials:
References: