Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone.

The main questions it aims to answer are:

Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs?

Participants 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years and ≤ 85 years

After a radical mastectomy, further postoperative adjuvant chemotherapy with docetaxel combined with cyclophosphamide regimen is required.

ECOG performance status score of 0-2.

Normal hematological function (platelet count > 80×10⁹/L; white blood cell count > 3×10⁹/L; neutrophil count > 1.5×10⁹/L).

Disqualifiers

Local inflammation or infection of the auricle

Bleeding tendency or coagulation disorders

Severe ascites

Gastrointestinal obstruction

Trial design

Design model

Single group

Treatments tested in this trial

  • Auricular point stimulation plus dexamethasone

    Other intervention

    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, noon, and 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Auricular point stimulation plus dexamethasone groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0

Participants will be asked to fill out a questionnaire to record whether nausea occurs. If nausea occurs, its grade according to the NIC-CTC AE4.0 should be recorded.

Time frame
from the day of chemotherapy (Day 1) until the end of Day 5

Secondary outcomes

1

Proportion of patients experiencing vomiting as assessed by NIC-CTC AE4.0

Participants will be asked to fill out a questionnaire to record whether vomiting occurs. If vomiting occurs, its grade according to the NIC-CTC AE4.0 should be recorded.

Time frame
from the day of chemotherapy (Day 1) until the end of Day 5
2

Proportion of patients requiring additional antiemetics

Time frame
from the day of chemotherapy (Day 1) until Day 5

Other outcomes

1

Proportion of patients experiencing chemotherapy-related adverse events as assessed by CTCAE v4.0

Time frame
from the day of chemotherapy (Day 1) until Day 5

Sponsors and contacts

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