Using electroacupuncture to prevent nausea and vomiting in breast cancer patients undergoing chemotherapy
A Study on Electroacupuncture Combined With Olanzapine-contained Four-drug Antiemetic Therapy for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer (ECO Study)
This study is testing if adding electroacupuncture to regular anti-nausea medications can help breast cancer patients undergoing chemotherapy avoid nausea and vomiting.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Qinghai University Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide |
| Locations | 1 site (Xining, Qinghai) |
| Trial ID | NCT06200168 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness of electroacupuncture combined with standard antiemetic drugs in preventing nausea and vomiting in breast cancer patients receiving highly emetogenic chemotherapy. Participants will be randomly assigned to receive either electroacupuncture or sham acupuncture alongside olanzapine and other antiemetic medications. The study will also investigate the potential relationship between genetic factors and the effectiveness of electroacupuncture. Outcomes will include the frequency of nausea and vomiting, use of rescue medications, and any adverse events.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 18 to 75 who are about to undergo highly emetogenic chemotherapy and have not received prior chemotherapy.
Not a fit: Patients who have already undergone chemotherapy or are scheduled for non-highly emetogenic chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chemotherapy-induced nausea and vomiting, improving the quality of life for breast cancer patients.
How similar studies have performed: Previous studies have shown promising results for acupuncture in managing chemotherapy-induced nausea and vomiting, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Xining, Qinghai
- Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.