Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

388

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Standard Quadruple Antiemetic TherapyElectroacupunctureChemotherapy-induced Gastrointestinal Symptom Cluster
Interventions
DEVICE

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.

DRUG

standard quadruple antiemetic therapy

Olanzapine 2.5 mg orally daily on days 1 to 4; dexamethasone 10 mg intravenously on day 1, and 7.5 mg intravenously on days 2 to 3; palonosetron 0.25 mg intravenously on day 1, or ondansetron 8 mg intravenously on day 1, or tropisetron 5 mg intravenously on day 1; and fosaprepitant 150 mg intravenously on day 1, or aprepitant 130 mg intravenously on day 1, or aprepitant 125 mg orally on day 1 followed by 80 mg orally on days 2 to 3.

DEVICE

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.

DRUG

standard quadruple antiemetic therapy

Olanzapine 2.5 mg orally daily on days 1 to 4; dexamethasone 10 mg intravenously on day 1, and 7.5 mg intravenously on days 2 to 3; palonosetron 0.25 mg intravenously on day 1, or ondansetron 8 mg intravenously on day 1, or tropisetron 5 mg intravenously on day 1; and fosaprepitant 150 mg intravenously on day 1, or aprepitant 130 mg intravenously on day 1, or aprepitant 125 mg orally on day 1 followed by 80 mg orally on days 2 to 3. All the antiemetic drugs used are the same as those in the true acupuncture group.

Trial Locations (1)

810000

Qinghai University Affiliated Hospital, Xining

All Listed Sponsors
lead

Jiuda Zhao

OTHER