Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

NCT06952920 | Recruiting Phase 3 DMC

• 1 other identifier: AHQU-2025002
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy.

  120 hours

Secondary Outcomes (6)

• 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

Other Outcomes (2)

• Exploratory multi-omics analysis of electroacupuncture's modulation on symptom clusters.

  From enrollment through the entire chemotherapy cycle (up to 8 cycles, each cycle is 21 days; maximum 64 weeks)

• Association between electroacupuncture and pathological complete response rate in patients receiving neoadjuvant therapy.

  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)

Study Arms (2)

true acupuncture + standard quadruple antiemetic therapy

EXPERIMENTAL

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.

Device: electroacupuncture; Drug: standard quadruple antiemetic therapy

sham acupuncture + standard quadruple antiemetic therapy

PLACEBO COMPARATOR

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.

Device: sham electroacupuncture; Drug: standard quadruple antiemetic therapy

Interventions

electroacupuncture DEVICE

The 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.

true acupuncture + standard quadruple antiemetic therapy

sham electroacupuncture DEVICE

The 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.

sham acupuncture + standard quadruple antiemetic therapy

standard quadruple antiemetic therapy DRUG

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).

true acupuncture + standard quadruple antiemetic therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

Related Publications (1)

• Tao X, Liu Z, Wang M, Ren D, Zhao F, Wang H, Yang G, Zhang G, Li Z, Liu Z, Huang S, Chen Y, Da M, Ma X, Liang H, Li Y, Ye Y, Zheng Y, Liang X, Shen G, Bai X, Zhao J. Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial. Health Care Sci. 2026 Feb 17;5(1):85-94. doi: 10.1002/hcs2.70056. eCollection 2026 Feb.

  PMID: 41767166 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)