RecruitingPhase 3NCT06952920

Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer

Sponsor

Jiuda Zhao

Enrollment

388 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Standard Quadruple Antiemetic Therapy Electroacupuncture Chemotherapy-induced Gastrointestinal Symptom Cluster

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether electroacupuncture (a form of acupuncture using mild electrical stimulation) can help reduce nausea, vomiting, and other gut-related side effects in breast cancer patients undergoing chemotherapy. Researchers want to know if this approach works better than no acupuncture during treatment. **You may be eligible if...** - You have been diagnosed with early-stage breast cancer (stage I–III) - You are scheduled to begin a first round of chemotherapy with drugs known to cause significant nausea (such as EC or platinum-based regimens) - You are between 18 and 75 years old - You have not had acupuncture in the past month **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You are receiving radiation and chemotherapy at the same time - You are pregnant or breastfeeding - You already have nausea or vomiting from a digestive condition unrelated to cancer - You are currently taking anti-nausea medications (such as certain serotonin blockers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEelectroacupuncture

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.

DRUGstandard 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).

DEVICEsham 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.

DRUGstandard quadruple antiemetic therapy