Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

January 16, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions
ElectroacupunctureOlanzapine-contained Four-drug AntiemeticNausea and Vomiting
Interventions
DEVICE

Electroacupuncture

"The acupuncturists will insert needles into the acupoints and manipulate the needles untilde qisensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz."

DRUG

Standard antiemetic treatment

Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.

DEVICE

Sham electroacupuncture

"The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group.Care was taken to avoid de qi sensation."

DRUG

Standard antiemetic treatment

Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.All the antiemetic drugs used are the same as those in the true acupuncture group.

Trial Locations (1)

810000

RECRUITING

Qinghai University Affiliated Hospital, Xining

All Listed Sponsors
lead

Jiuda Zhao

OTHER