Clinical trial · Interventional
Personalized Electroacupuncture Treatment for Chemotherapy-induced Nausea and Vomiting in Breast Cancer (PET)
Personalized Electroacupuncture Treatment Combined With Standard Antiemetic Drugs for Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer Receiving Highly Emetogenic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate electroacupuncture as an antiemetic treatment compared with sham acupuncture in patients with breast cancer, receiving highly emetogenic chemotherapy (HEC). Moreover, it will analyze the association between single nucleotide polymorphism and the antiemetic outcomes of electroacupuncture.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham acupuncture + standard antiemetic treatment | Procedure | — | UNRESOLVED |
| True acupuncture + standard antiemetic treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- True acupuncture + standard antiemetic treatment
- interventionNames
- Procedure: True acupuncture + standard antiemetic treatment
- type
- PLACEBO_COMPARATOR
- label
- Sham acupuncture + standard antiemetic treatment
- interventionNames
- Procedure: Sham acupuncture + standard antiemetic treatment
Primary outcomes (1)
- measure
- Proportion of Patients With Significant Nausea, Rescue Treatment and Number of Times of Vomiting Occurs After chemotherapy (complete protection).
- timeFrame
- 120 hours
- description
- The proportion of patients achieving complete protection is defined as patients who have no vomiting, no rescue treatment, no significant nausea that was assessed by visual analog scale (VAS, this is a Visual Analogue Scale was used to assess the incidence and intensity of nausea daily, a 100-mm horizontal bar containing no marking except for the anchor point at each end: left, no nausea; right, worst nausea. No nausea was defined as a VAS scores \< 5mm, no significant nausea was defined as a VAS scores \< 25mm), and maximum less than 25 mm during the first 120 hours after the initiation of chemotherapy (The definition is different from the complete response in the "Secondary endpoints" section).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years of age or older, of any nationality; 2. Eastern Cooperative Oncology Group performance status of 0-2; 3. For patients with breast cancer, molecular typing is not limited, receiving for the first time chemotherapy with anthracyclines+ cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin -based HEC regimen. Patients with previous chemotherapy use could be enrolled if they received it \>3 months; 4. Predicted life expectancy of ≥3 months; 5. Adequate bone marrow, kidney, and liver function; 6. Adequate contraception if premenopausal women; 7. Written informed consent by the patient before enrolment. Exclusion Criteria: 1. Patients already submitted to chemotherapy; 2. Is scheduled to receive any non-HEC on Day 1; 3. 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; 4. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting; 5. Have ongoing emesis or CTCAE grade 2 or greater nausea; 6. Significant mental conditions; 7. Any allergies to study drug, antiemetics or dexamethasone; 8. Significantly abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine); 9. Patients who are pregnant or breast-feeding; 10. Inflammatory skin reaction; 11. Has lymphedema in acupuncture stimulation area; 12. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles; 13. Received acupuncture treatments for any conditions less than 4 weeks before HEC; 14. The current use of any drugs with antiemetic activity (e.g. 5-HT3 RA, dopamine receptor antagonist, minor tranquilizer, antihistamine); 15. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, hypercalcemia and symptomatic brain metastasis; 16. Patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy; 17. Patients receiving concomitant steroids, except when administered at physiologic doses; 18. Patients receiving concomitant benzodiazepines, except when used for nocturnal sedation.
References
Publications (1)
- DERIVEDShen G, Ren D, Zhao F, Wang M, Liu Z, Feng X, He Y, Liu X, Ling X, Zhao Y, Song F, Ma J, Li E, She T, Liu Z, Li Z, Huang S, Chen Y, Yang J, Li X, Duan L, Da M, Zheng Y, Li Y, Zhao J. Effect of Adding Electroacupuncture to Standard Triple Antiemetic Therapy on Chemotherapy-Induced Nausea and Vomiting: A Randomized Controlled Clinical Trial. J Clin Oncol. 2024 Dec;42(34):4051-4059. doi: 10.1200/JCO.24.00099. Epub 2024 Sep 6. PMID 39241208