Personalized Electroacupuncture Treatment for Chemotherapy-induced Nausea and Vomiting in Breast Cancer (PET)

This is an interventional treatment trial for Cancer focused on measuring electroacupuncture treatment, chemotherapy-induced nausea, chemotherapy-induced vomiting, breast cancer Read More

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.