Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT06952920
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically confirmed stage I-III breast cancer;
2. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
3. Age between 18 and 75 years;
4. Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy;
5. No prior acupuncture treatment within one month before enrollment;
6. Voluntary participation in the study with written informed consent obtained; (7) An expected survival of at least 3 months;
(8) Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria.
Exclusion Criteria:
1. Patients with advanced-stage cancer;
2. Those undergoing concurrent chemoradiotherapy;
3. Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
4. Patients with contraindications to acupuncture, such as active skin infections;
5. Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
6. Patients with a history of xerostomia;
7. Individuals with known allergies to the study drugs;
8. Pregnant or breastfeeding patients;
9. Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation);
10. Patients with seizure disorders requiring anticonvulsant therapy;
11. Those receiving thiazides as chronic antipsychotic medications;
12. Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06952920
Study Brief:
Protocol Section:
NCT06952920