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Prevention study for Electroacupuncture
Official title Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
ClinicalTrials.gov ID: NCT06200168
What this study is testing
What is Standard antiemetic treatment?
Standard antiemetic treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for electroacupuncture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Predicted life expectancy of ≥3 months;
- Adequate bone marrow, kidney, and liver function;
You likely can't join if
- 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...
- 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;
See the full eligibility 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...
- 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Xining, Qinghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xining, Qinghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.