Auricular Acupressure for Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy

NCT07760766 · tracked via the Priya Life Science China tracker

Sponsor

China Medical University, China

Phase

Not applicable

Started

2026-09

Last updated

2026-08-12

Condition(s) studied

Chemotherapy-induced Nausea and Vomiting

Investigational drug(s) / intervention(s)

Auricular AcupressureSham Auricular Acupressure

Auricular Acupressure: Auricular acupressure will be administered using Vaccaria seed ear patches applied to protocol-specified therapeutic auricular acupoints, including Shenmen, Stomach, Sympathetic, and other designated points. Participants will be instructed to perform self-acupressure according to the study protocol during the intervention period

Sham Auricular Acupressure: Sham auricular acupressure will be administered using identical Vaccaria seed ear patches applied to non-therapeutic auricular points located in the earlobe area. Participants will receive the same self-acupressure instructions and treatment schedule as those in the active intervention group.

Study summary

Chemotherapy-induced nausea and vomiting (CINV) remains one of the most common and distressing adverse effects in patients receiving highly emetogenic chemotherapy (HEC). Despite the widespread use of guideline-recommended triple antiemetic therapy, a substantial proportion of patients continue to experience delayed-phase nausea and vomiting, which negatively affect treatment adherence, nutritional status, and quality of life. Effective strategies for improving delayed CINV control remain an important unmet clinical need.

Auricular acupressure is a noninvasive traditional Chinese medicine intervention that has been widely used for the management of gastrointestinal symptoms and supportive care in patients with cancer. However, current evidence regarding its effectiveness in preventing CINV is limited by small sample sizes, methodological heterogeneity, and insufficient evaluation of delayed-phase outcomes.

This multicenter, randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and safety of auricular acupressure as an adjunct to standard triple antiemetic therapy for the prevention of CINV in patients receiving HEC. A total of 332 eligible participants will be randomly assigned in a 1:1 ratio to receive either auricular acupressure or sham auricular acupressure in addition to standard antiemetic treatment.

The primary outcome is the complete protection rate during the delayed phase (24-120 hours) of the first chemotherapy cycle, defined as no vomiting, no use of rescue medication, and a nausea visual analogue scale (VAS) score below 25 mm. Secondary outcomes include complete protection, complete response, total control, nausea severity, vomiting episodes, rescue medication use, appetite changes, quality of life assessed by the Functional Living Index-Emesis (FLIE) and EORTC QLQ-C30, treatment adherence, and safety outcomes across multiple chemotherapy cycles.

The findings of this study are expected to provide high-quality evidence regarding the role of auricular acupressure in the prevention of delayed CINV and support its integration into evidence-based supportive cancer care.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria * Age 18-75 years, either sex. * Malignant solid tumor confirmed by histopathology. ③ Chemotherapy-naïve, planned to receive a single-day intravenous highly emetogenic chemotherapy (HEC) regimen, including: * Cisplatin-containing regimens (dose ≥50 mg/m²); * Anthracycline plus cyclophosphamide (AC/EC) regimens; * Carboplatin AUC ≥4; * Other highly emetogenic chemotherapy regimens recognized by guidelines. ④ In accordance with guideline recommendations for HEC regimens, the triple regimen of NK-1 RA + 5-HT₃ RA + dexamethasone is used: ⑤ ECOG performance status score 0-1. ⑥ Life expectancy ≥ 6 months. ⑦ Voluntarily signed informed consent, and able to understand and complete the patient diary. Exclusion Criteria * Nausea or vomiting already present within 24 hours prior to enrollment. * Symptomatic brain metastases, gastrointestinal obstruction, or other organic diseases likely to cause nausea and vomiting. * Local skin breakdown, infection, or deformity of the auricle, or allergy to adhesive tape/Vaccaria seeds (Wang Bu Liu Xing). ④ Planned use of olanzapine, thalidomide, or other antiemetic agents not specified in the protocol as part of the routine prophylactic antiemetic regimen during this chemotherapy cycle (i.e., those receiving a quadruple regimen or other non-standard prophylactic regimens). ⑤ Long-term regular use (e.g., more than 3 times per week) of benzodiazepines, antipsychotics, or sedative-hypnotics; or known history of drug abuse/dependence. ⑥ Severe mental illness or cognitive impairment that precludes cooperation with assessments. ⑦ Receipt of ear acupuncture or auricular acupressure (ear seeds) within 4 weeks prior to enrollment. ⑧ Pregnant or lactating women.

Primary outcome measure(s)

Complete Protection (CP) Rate During the Delayed Phase of Cycle 1 — 24 to 120 hours after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).
Complete protection (CP) during the delayed phase (24-120 hours after chemotherapy) in Cycle 1, defined as no vomiting, no use of rescue antiemetic medication, and a nausea visual analogue scale (VAS) score \<25 mm.

Trial sites (1)

Facility	City	Region	Status
The First Hospital of China Medical University	Shenyang	Liaoning

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07760766 on ClinicalTrials.gov ↗ ← All trials in China