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:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT05275569
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older, of any nationality;
2. Eastern Cooperative Oncology Group performance status of 0-2;
3. For patients with breast cancer, molecular typing is not limited, receiving for the first time chemotherapy with anthracyclines+ cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin -based HEC regimen. Patients with previous chemotherapy use could be enrolled if they received it \>3 months;
4. Predicted life expectancy of ≥3 months;
5. Adequate bone marrow, kidney, and liver function;
6. Adequate contraception if premenopausal women;
7. Written informed consent by the patient before enrolment.
Exclusion Criteria:
1. Patients already submitted to chemotherapy;
2. Is scheduled to receive any non-HEC on Day 1;
3. Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;
4. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
5. Have ongoing emesis or CTCAE grade 2 or greater nausea;
6. Significant mental conditions;
7. Any allergies to study drug, antiemetics or dexamethasone;
8. Significantly abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine);
9. Patients who are pregnant or breast-feeding;
10. Inflammatory skin reaction;
11. Has lymphedema in acupuncture stimulation area;
12. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
13. Received acupuncture treatments for any conditions less than 4 weeks before HEC;
14. The current use of any drugs with antiemetic activity (e.g. 5-HT3 RA, dopamine receptor antagonist, minor tranquilizer, antihistamine);
15. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, hypercalcemia and symptomatic brain metastasis;
16. Patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy;
17. Patients receiving concomitant steroids, except when administered at physiologic doses;
18. Patients receiving concomitant benzodiazepines, except when used for nocturnal sedation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05275569
Study Brief:
Protocol Section:
NCT05275569