Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer

Launched by JIUDA ZHAO · Dec 29, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of electroacupuncture, a treatment that involves applying small electrical pulses through needles inserted into the skin, to help prevent nausea and vomiting caused by chemotherapy in patients with breast cancer. Researchers are comparing this method to standard anti-nausea medications that include olanzapine and three other drugs. Additionally, the study will look into how certain genetic factors might affect the effectiveness of electroacupuncture for managing these side effects.

To participate in this study, individuals must be between 18 and 75 years old, have a diagnosis of breast cancer, and be starting a specific type of chemotherapy that is known to cause nausea (highly emetogenic chemotherapy). Participants must not have received chemotherapy in the past three months and should be able to give informed consent. Those who join the trial can expect to receive either the electroacupuncture treatment or the standard anti-nausea medications, and they will be monitored for their experiences with nausea and vomiting during their chemotherapy sessions. It's important to note that there are some health conditions and treatments that could prevent someone from being eligible, so discussing individual health situations with a doctor is essential.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 years or older and aged 75 years or younger, of any nationality;
• • 2. Eastern Cooperative Oncology Group performance status of 0-2;
• • 3. Patients with breast cancer, with no restrictions on molecular typing; early-stage patients must not have undergone prior chemotherapy, while advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin;
• • 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. Is scheduled to receive any chemotherapy on days 2-4 after HEC;
• • 4. 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;
• • 5. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
• • 6. Have ongoing emesis or CTCAE grade 2 or greater nausea;
• • 7. Significant medical or mental conditions;
• • 8. Any allergies to study drug, antiemetics or dexamethasone;
• • 9. Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);
• • 10. Patients who are pregnant or breast-feeding;
• • 11. Inflammatory skin reaction;
• • 12. Has lymphedema in acupuncture stimulation area;
• • 13. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
• • 14. Received acupuncture treatments for any conditions less than 4 weeks before HEC;
• • 15. Currently using drugs with antiemetic activity (e.g., 5-HT3 receptor antagonists, corticosteroids (except when used at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nocturnal sedation));
• • 16. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;
• • 17. Has a convulsive disorder requiring anticonvulsant treatment;
• • 18. Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);
• • 19. Concurrent treatment with quinolone antibiotics;
• • 20. Has a history of chronic alcoholism (determined by the investigator);
• • 21. Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;
• • 22. Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).