NCT06314906 Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
| NCT ID | NCT06314906 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Feixue Song |
| Condition | Electroacupuncture |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 370 participants in total. It began in 2024-03-07 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 75 years, inclusive, from any nationality. 2. Patients diagnosed with early-stage breast cancer. 3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2. 4. All patients must undergo highly emetogenic chemotherapy (HEC). 5. Adequate organ function. 6. Adequate contraception required for premenopausal women. Exclusion Criteria: 1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC. 2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1. 3. Significant medical or psychological conditions. 4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting. 5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE). 6. Any known allergies to the study drug, antiemetics, or dexamethasone. 7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles. 8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06314906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Electroacupuncture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06314906 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 370 participants.
Is NCT06314906 currently recruiting?
Yes, NCT06314906 is actively recruiting participants. Contact the research team at 13639336037@139.com for enrollment information.
Where is the NCT06314906 trial being conducted?
This trial is being conducted at Lanzhou, China.
Who is sponsoring the NCT06314906 clinical trial?
NCT06314906 is sponsored by Feixue Song. The trial plans to enroll 370 participants.