Patient-Controlled Real-Time Transcutaneous Electrical Acupoint Stimulation at Neiguan (PC6) for Chemotherapy-Induced Nausea and Vomiting in Breast Cancer: An Exploratory Single-Arm Two-Stage Trial
Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Recruitment
2.2. Diagnostic Criteria
- Diagnosis of breast cancer confirmed by pathological or cytological examination.
- Chemotherapy regimen includes emetogenic agents such as anthracyclines, cisplatin, the AC regimen (doxorubicin or epirubicin + cyclophosphamide), or carboplatin (AUC ≥ 4).
- Presence of nausea, retching, or vomiting during the chemotherapy phase.
2.3. Inclusion Criteria
- Met the diagnostic criteria and are aged 20 to 75 years.
- Experience CINV symptoms during the most recent chemotherapy cycle.
- Plan to receive at least two consecutive chemotherapy cycles with unchanged chemotherapy and antiemetic regimens in both cycles.
- Karnofsky Performance Status (KPS) ≥ 60.
- Expected survival of at least 6 months.
- Ability to understand study procedures and complete questionnaires.
- Provide written informed consent.
- No acupuncture or related therapies (e.g., electroacupuncture, TEAS) within 4 weeks prior to enrollment.
2.4. Exclusion Criteria
- Concurrent radiotherapy or other anti-cancer therapies during the study period.
- Gastrointestinal disorders or other medical conditions that may independently cause nausea or vomiting.
- Severe psychiatric disorders or cognitive impairment that may affect compliance.
- Skin lesions, infection, or allergy at the PC6 acupoint.
- Peripheral neuropathy that may interfere with TEAS application.
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Inability to comply with study procedures or follow instructions.
2.5. Diagnostic and Chemotherapy Rationale
2.6. Intervention: Patient-Controlled, Real-Time TEAS
2.6.1. Device and Acupoint
2.6.2. Device Parameters
2.6.3. Intervention Schedule
2.7. Safety and Monitoring
2.8. Outcome Measures
2.8.1. Primary Decision Endpoint and Exploratory Clinical Outcomes
2.8.2. Secondary Outcomes
- Quality of life, assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
- Anxiety, measured using the Self-Rating Anxiety Scale (SAS); scores of 50–59, 60–69, and ≥70 indicate mild, moderate, and severe anxiety, respectively.
- Depression, measured using the Self-Rating Depression Scale (SDS); index scores of <0.50, 0.50–0.59, 0.60–0.69, and ≥0.70 indicate no depression and mild, moderate, and severe depression, respectively.
- General information, including demographic characteristics, medical history, comorbidities, and medication use.
- Safety outcomes, including TEAS-related skin irritation, local discomfort, numbness, palpitations, and other adverse events.
2.9. Response Evaluation
2.10. Sample Size Calculation
2.11. Statistical Analysis
2.12. Safety Assessment
3. Results
3.1. Baseline Characteristics
3.2. Primary and Exploratory Outcome
3.2.1. First-Stage Efficacy Outcomes and Justification for Proceeding to the Second Stage
3.2.2. Full-Cohort Outcomes After Completion of the Second Stage
3.2.3. Paired Changes in Nausea and Vomiting Grades Between the Observation and TEAS Intervention Periods
3.2.4. Nausea and Vomiting Frequency and Severity During the Observation and TEAS Intervention Periods
3.3. Secondary Outcomes
3.4. Device Utilization and Safety Outcomes
4. Discussion
Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
| Obs | Observation period |
| CINV | Chemotherapy-induced nausea and vomiting |
| TEAS | Transcutaneous electrical acupoint stimulation |
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| Item | Grade 0 | Grade I | Grade II | Grade III |
|---|---|---|---|---|
| Nausea | No nausea | Mild nausea without affecting food intake or daily life | Moderate nausea affecting food intake or daily life | Severe nausea, bedridden due to nausea |
| Vomiting | No vomiting | 1–2 times/day | 3–5 times/day | >5 times/day |
| Efficacy evaluation | Complete response | Partial response | No response | |
| Item | Result | |||
|---|---|---|---|---|
| Height, cm, mean ± SD (range) | 161.3 ± 2.4 (157.0–166.0) | |||
| Weight, kg, mean ± SD (range) | 49.5 ± 3.5 (43.6–56.5) | |||
| BMI, kg/m2, mean ± SD (range) | 18.9 ± 1.1 (17.1–21.2) | |||
| Age, years, mean ± SD (range) | 49.21 ± 9.66 (32–74) | |||
| Interval between chemotherapy cycles, days, mean ± SD (range) | 19.01 ± 7.77 (6–41) | |||
| KPS score, mean ± SD (range) | 74.38 ± 9.43 (60–90) | |||
| Tumor stage n (%) | Stage I | Stage II | Stage III | Stage IV |
| 1 (2.1) | 4 (8.3) | 5 (10.4) | 38 (79.2) | |
| Outcome | Time | Observation Responders, n (%) | TEAS Responders, n (%) | Non-Response → Response, n | Response → Non-Response, n | Difference, Percentage Points | Exact McNemar p |
|---|---|---|---|---|---|---|---|
| Nausea | Day 1 | 12 (25.00) | 36 (75.00) | 24 | 0 | 50.00 | <0.001 |
| Nausea | Day 2 | 19 (39.58) | 34 (70.83) | 17 | 2 | 31.25 | <0.001 |
| Nausea | Day 3 | 24 (50.00) | 41 (85.42) | 18 | 1 | 35.42 | <0.001 |
| Nausea | Day 4 | 35 (72.92) | 44 (91.67) | 10 | 1 | 18.75 | 0.012 |
| Nausea | Day 5 | 42 (87.50) | 46 (95.83) | 4 | 0 | 8.33 | 0.125 |
| Vomiting | Day 1 | 44 (91.67) | 48 (100.00) | 4 | 0 | 8.33 | 0.125 |
| Vomiting | Day 2 | 46 (95.83) | 47 (97.92) | 2 | 1 | 2.09 | 1.000 |
| Vomiting | Day 3 | 48 (100.00) | 47 (97.92) | 0 | 1 | −2.08 | 1.000 |
| Vomiting | Day 4 | 47 (97.92) | 45 (93.75) | 1 | 3 | −4.17 | 0.625 |
| Vomiting | Day 5 | 47 (97.92) | 43 (89.58) | 0 | 4 | −8.34 | 0.125 |
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Share and Cite
Liu, H.; Zhou, J.; Du, J.; Shen, Q.; Lu, C.; Zhang, J.; Zhang, W.; Ran, R.; Fang, J.; Ye, J.; et al. Patient-Controlled Real-Time Transcutaneous Electrical Acupoint Stimulation at Neiguan (PC6) for Chemotherapy-Induced Nausea and Vomiting in Breast Cancer: An Exploratory Single-Arm Two-Stage Trial. Curr. Oncol. 2026, 33, 520. https://doi.org/10.3390/curroncol33090520
Liu H, Zhou J, Du J, Shen Q, Lu C, Zhang J, Zhang W, Ran R, Fang J, Ye J, et al. Patient-Controlled Real-Time Transcutaneous Electrical Acupoint Stimulation at Neiguan (PC6) for Chemotherapy-Induced Nausea and Vomiting in Breast Cancer: An Exploratory Single-Arm Two-Stage Trial. Current Oncology. 2026; 33(9):520. https://doi.org/10.3390/curroncol33090520
Chicago/Turabian StyleLiu, Huiting, Jie Zhou, Junying Du, Qiongying Shen, Chao Lu, Jianxing Zhang, Weiping Zhang, Ran Ran, Jianqiao Fang, Jiongyao Ye, and et al. 2026. "Patient-Controlled Real-Time Transcutaneous Electrical Acupoint Stimulation at Neiguan (PC6) for Chemotherapy-Induced Nausea and Vomiting in Breast Cancer: An Exploratory Single-Arm Two-Stage Trial" Current Oncology 33, no. 9: 520. https://doi.org/10.3390/curroncol33090520
APA StyleLiu, H., Zhou, J., Du, J., Shen, Q., Lu, C., Zhang, J., Zhang, W., Ran, R., Fang, J., Ye, J., Gao, H., & Fang, J. (2026). Patient-Controlled Real-Time Transcutaneous Electrical Acupoint Stimulation at Neiguan (PC6) for Chemotherapy-Induced Nausea and Vomiting in Breast Cancer: An Exploratory Single-Arm Two-Stage Trial. Current Oncology, 33(9), 520. https://doi.org/10.3390/curroncol33090520

