NCT06952920 Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer
| NCT ID | NCT06952920 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiuda Zhao |
| Condition | Standard Quadruple Antiemetic Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 388 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 388 participants in total. It began in 2025-08-21 with a primary completion date of 2028-06-30.
⚠ 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 aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify the key targets of electroacupuncture intervention, thereby providing high-level evidence-based medical support and theoretical foundations for optimizing electroacupuncture strategies in addressing chemotherapy-induced gastrointestinal symptoms in patients with cancer.
Eligibility Criteria
Inclusion Criteria: 1. Radiologically and pathologically confirmed stage I-III breast cancer; 2. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1; 3. Age between 18 and 75 years; 4. Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy; 5. No prior acupuncture treatment within one month before enrollment; 6. Voluntary participation in the study with written informed consent obtained; (7) An expected survival of at least 3 months; (8) Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria. Exclusion Criteria: 1. Patients with advanced-stage cancer; 2. Those undergoing concurrent chemoradiotherapy; 3. Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy; 4. Patients with contraindications to acupuncture, such as active skin infections; 5. Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment; 6. Patients with a history of xerostomia; 7. Individuals with known allergies to the study drugs; 8. Pregnant or breastfeeding patients; 9. Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation); 10. Patients with seizure disorders requiring anticonvulsant therapy; 11. Those receiving thiazides as chronic antipsychotic medications; 12. Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
Frequently Asked Questions
Who can join the NCT06952920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Standard Quadruple Antiemetic Therapy. 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 NCT06952920 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 388 participants.
Is NCT06952920 currently recruiting?
Yes, NCT06952920 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jiuda Zhao to inquire about joining.
Where is the NCT06952920 trial being conducted?
This trial is being conducted at Xining, China.
Who is sponsoring the NCT06952920 clinical trial?
NCT06952920 is sponsored by Jiuda Zhao. The trial plans to enroll 388 participants.