Ear acupressure plus dexamethasone to prevent chemo nausea from docetaxel and cyclophosphamide
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Combined With Cyclophosphamide in Breast Cancer Adjuvant Chemotherapy
This trial will test whether ear acupressure (auricular point stimulation) combined with dexamethasone can prevent or reduce nausea and vomiting in adults receiving docetaxel plus cyclophosphamide after breast cancer surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT07537699 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study gives participants auricular acupressure (bean seeds applied to specific points on one ear) together with an intravenous dose of dexamethasone as a preventive antiemetic when they receive docetaxel plus cyclophosphamide for adjuvant breast cancer chemotherapy. The study will monitor rates and severity of chemotherapy-induced nausea and vomiting (CINV) in the days around each chemotherapy administration and record gastrointestinal symptoms such as appetite loss, constipation, and diarrhea. Safety assessments will include local auricle reactions and overall effects on gastrointestinal function and laboratory tests. The goal is to see if adding auricular stimulation allows effective CINV control with fewer or lower-intensity antiemetic medications and better patient comfort.
Who should consider this trial
Good fit: Adults aged 18–85 who have had radical mastectomy and are planned for adjuvant docetaxel plus cyclophosphamide chemotherapy with ECOG 0–2 and adequate blood, liver, and kidney function are the intended participants.
Not a fit: Patients with local ear inflammation or infection, bleeding or coagulation disorders, severe ascites, or who cannot receive dexamethasone are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could reduce chemotherapy-related nausea and vomiting and lower the need for high-intensity antiemetic drugs, improving gastrointestinal function and quality of life.
How similar studies have performed: Previous trials of auricular acupuncture or acupressure have shown modest benefit for postoperative and some chemotherapy-related nausea, but evidence is mixed and limited for this specific chemo regimen.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou
- Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Juan Wang
- Email: wangjuan.happy@hotmail.com
- Phone: 8617816190946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.