Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Wit… (NCT06200168) | Clinical Trial Compass
RecruitingPhase 3
Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
China370 participantsStarted 2024-01-16
Plain-language 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 vomiting induced by highly emetogenic chemotherapy (HEC) in patients with breast cancer. Furthermore, it will analyze the relationship between single nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea and vomiting.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with no nausea during the overall stage
. Written informed consent by the patient before enrolment.
Exclusion criteria
. 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;