Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

NCT ID: NCT06952920

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2028-06-30

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.

Conditions

Standard Quadruple Antiemetic Therapy; Electroacupuncture; Chemotherapy-induced Gastrointestinal Symptom Cluster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: 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.

standard quadruple antiemetic therapy

Intervention Type: 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).

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.

Group Type: PLACEBO_COMPARATOR

sham electroacupuncture

Intervention Type: 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.

standard quadruple antiemetic therapy

Intervention Type: 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). All the antiemetic drugs used are the same as those in the true acupuncture group.

Interventions

electroacupuncture

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.

Intervention Type: DEVICE

standard quadruple antiemetic therapy

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).

Intervention Type: DRUG

sham electroacupuncture

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.

Intervention Type: DEVICE

standard quadruple antiemetic therapy

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). All the antiemetic drugs used are the same as those in the true acupuncture group.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiuda Zhao

OTHER

Sponsor Role: lead

Responsible Party

Jiuda Zhao

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jiuda Zhao，Dr

Role: primary

jiudazhao@126.com

869716230893

Other Identifiers

AHQU-2025002

Identifier Type: -

Identifier Source: org_study_id