Status:
RECRUITING
Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
Lead Sponsor:
Jiuda Zhao
Conditions:
Electroacupuncture
Olanzapine-contained Four-drug Antiemetic
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This randomized controlled phase III trial aims to evaluate the use of electroacupuncture in combination with olanzapine-containing standard quadruple antiemetic drugs for the treatment of nausea and ...
Detailed Description
This study is a parallel-group, blinded (participants, evaluators, and statisticians), randomized controlled trial exploring the effectiveness of electroacupuncture combined with standard quadruple an...
Eligibility Criteria
Inclusion
- Aged 18 years or older and aged 75 years or younger, of any nationality;
- Eastern Cooperative Oncology Group performance status of 0-2;
- 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;
- Predicted life expectancy of ≥3 months;
- Adequate bone marrow, kidney, and liver function;
- Adequate contraception if premenopausal women;
- Written informed consent by the patient before enrolment.
Exclusion
- Patients already submitted to chemotherapy;
- Is scheduled to receive any non-HEC on Day 1;
- Is scheduled to receive any chemotherapy on days 2-4 after HEC;
- 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;
- Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
- Have ongoing emesis or CTCAE grade 2 or greater nausea;
- Significant medical or mental conditions;
- Any allergies to study drug, antiemetics or dexamethasone;
- Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);
- Patients who are pregnant or breast-feeding;
- Inflammatory skin reaction;
- Has lymphedema in acupuncture stimulation area;
- Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
- Received acupuncture treatments for any conditions less than 4 weeks before HEC;
- 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));
- Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;
- Has a convulsive disorder requiring anticonvulsant treatment;
- Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);
- Concurrent treatment with quinolone antibiotics;
- Has a history of chronic alcoholism (determined by the investigator);
- Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;
- Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06200168
Start Date
January 16 2024
End Date
December 31 2026
Last Update
April 2 2025
Active Locations (1)
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1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000