Electroacupuncture to reduce chemo-related nausea and other gut symptoms in breast cancer
Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer
This trial will test whether adding electroacupuncture to standard anti-nausea medications helps reduce nausea, vomiting, poor appetite, and dry mouth in breast cancer patients receiving highly emetogenic chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 388 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Qinghai University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Xining, Qinghai) |
| Trial ID | NCT06952920 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blind, sham-controlled multicenter trial comparing electroacupuncture plus standard quadruple antiemetic therapy to sham electroacupuncture with the same antiemetic regimen in early-stage breast cancer patients. True electroacupuncture is delivered once 1–2 hours before chemotherapy on Day 1 and daily on Days 2–4 for 30 minutes per session with low-frequency electrical stimulation, while controls receive a matched sham procedure. Daily assessments during Days 1–5 record incidence and severity of nausea, vomiting, poor appetite, and xerostomia, along with weight, ECOG, EQ-5D-5L, medication use, adverse events, laboratory tests, and periodic blood sampling for multi-omics and genomic analyses. Randomization and blinded sham control are designed to isolate the specific effect of electroacupuncture and to link clinical effects with biological mechanisms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with pathologically confirmed stage I–III breast cancer, ECOG 0–1, who are scheduled for a first cycle of highly emetogenic chemotherapy (e.g., EC or platinum-based regimens) and meet standard lab function criteria.
Not a fit: Patients with advanced-stage disease, those receiving concurrent chemoradiotherapy, those unable to tolerate standard-dose chemotherapy, or those who recently had acupuncture may not be eligible or likely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding electroacupuncture could reduce early-cycle chemotherapy-related nausea, vomiting, appetite loss, and dry mouth and improve short-term quality of life.
How similar studies have performed: Prior acupuncture and electroacupuncture studies show mixed but sometimes positive effects on chemo-related nausea and vomiting, while combining electroacupuncture with multi-omics and genomic endpoints is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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.
Where this trial is running
Xining, Qinghai
- Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.