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New treatment option for Nausea and Vomiting Caused by Chemotherapy
Official title Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide
ClinicalTrials.gov ID: NCT07537699
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patients must meet the following 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).
You likely can't join if
- 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
See the full eligibility criteria
- Patients must meet the following 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 \ 50ml/min.
- 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...
- 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...
- Inability or unwillingness to comply with the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.