NCT07537699 Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide
| NCT ID | NCT07537699 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Nausea and Vomiting Caused by Chemotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2025-11-25 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Patients must meet the following inclusion criteria for the study: * 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). * Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), and transaminase ≤ 5 times the ULN. * No ascites, no gastrointestinal obstruction, normal coagulation function, and serum albumin ≥ 30g/L. * Child-Pugh classification of liver function is Grade A. * Serum creatinine \< ULN, or calculated creatinine clearance rate \> 50ml/min. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study: * Local inflammation or infection of the auricle * Bleeding tendency or coagulation disorders * Severe ascites * Gastrointestinal obstruction * Hypertensive crisis or hypertensive encephalopathy * Severe uncontrolled systemic complications such as infection or diabetes mellitus * Clinically severe cardiovascular diseases, including cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), hypertension that is not well-controlled despite appropriate medication, unstable angina pectoris, congestive heart failure (NYHA Class 2-4), and cardiac arrhythmias requiring drug treatment * A history of or physical examination findings indicating central nervous system diseases (e.g., primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastasis or stroke) * Hypersensitivity to any drugs used in the study * Pregnant or lactating women * Presence of any other diseases, functional impairment caused by metastatic lesions, or suspicious disorders identified during physical examination, which suggest contraindications to the study drugs or place the patient at high risk of treatment-related complications * Inability or unwillingness to comply with the study protocol
Contact & Investigator
Juan Wang
STUDY CHAIR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT07537699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Nausea and Vomiting Caused by Chemotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07537699 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07537699 currently recruiting?
Yes, NCT07537699 is actively recruiting participants. Contact the research team at wangjuan.happy@hotmail.com for enrollment information.
Where is the NCT07537699 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07537699 clinical trial?
NCT07537699 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Juan Wang at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 25 participants.