Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide

Summary

This study aims to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen are non-inferior to the standard antiemetic regimen. Additionally, it will assess patients' appetite, gastrointestinal function, and other related indicators, and explore the significant role of integrated traditional Chinese medicine and Western medicine interventions in improving patients' quality of life during chemotherapy, thereby providing a clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen.

The main questions it aims to answer are: Whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen are non-inferior to the standard antiemetic regimen? In comparison with a standard pharmacologic antiemetic regimen, does auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions?

Breast cancer patients receiving adjuvant chemotherapy with the docetaxel plus cyclophosphamide regimen after surgery will be randomly assigned in a 1:1 ratio to either the auricular point stimulation group or the standard pharmacologic antiemetic regimen group. Patients in the auricular point stimulation group will: Receive auricular acupressure with bean seeds on specific points of one ear, plus intravenous injection of dexamethasone as a preventive antiemetic treatment within half an hour before chemotherapy. Starting from the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5), provide regular stimulation at the acupressure points daily by themselves according to the protocol provided in this trial. Record their nausea and vomiting status, appetite, and gastrointestinal function-related symptomatic indicators from Day 1 to Day 5. Oral antiemetics are also prepared. If nausea and vomiting are significant or the patient feels the need, they may be temporarily administered as an adjunct. Patients in the standard pharmacologic antiemetic regimen group will: Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines.

Conditions

• Nausea and Vomiting Caused by Chemotherapy

Interventions

DRUG

Auricular point stimulation plus dexamethasone

On the day of chemotherapy (Day 1): within half an hour before chemotherapy, administer auricular acupressure on one ear (stimulating the stomach, cardia, and brainstem acupoints for 5 minutes each) along with an intravenous push of 5 mg dexamethasone. From the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5): Stimulate each acupoint once in the morning, at noon, and in the evening, for 5 minutes each time. If nausea or vomiting occurs, immediately apply additional stimulation for 5 minutes as a temporary measure. Oral antiemetics should be prepared and may be used temporarily if nausea and vomiting are significant and the patient feels the need.

DRUG

Standard pharmacologic antiemetic regimen

Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines and patients' actual conditions, including dexamethasone ± 5-HT3 receptor inhibitor ± NK1 receptor inhibitor ± Olanzapine.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine

  lead OTHER

Principal Investigators

• Juan Wang · Second Affiliated Hospital, Zhejiang University, School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-12

Primary Completion

2026-12-06

Completion

2026-12-12

Countries

• China

Study Locations