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.
Age 18-75 years, either sex.
Malignant solid tumor confirmed by histopathology.
Cisplatin-containing regimens (dose ≥50 mg/m²);
Anthracycline plus cyclophosphamide (AC/EC) regimens;
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).
Parallel
Auricular Acupressure
Other interventionAuricular 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
Other interventionSham 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.
Complete Protection (CP) Rate During the Delayed Phase of Cycle 1
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.
Complete Protection Rate During the Acute and Overall Phases of Cycle 1
Proportion of participants achieving complete protection during the acute phase (0-24 hours) and overall phase (0-120 hours) of Cycle 1, defined as no vomiting, no use of rescue antiemetic medication, and no significant nausea (VAS score \<25 mm).
Complete Response Rate During Acute, Delayed, and Overall Phases of Cycle 1
Proportion of participants with no vomiting and no use of rescue antiemetic medication during the acute (0-24 hours), delayed (24-120 hours), and overall (0-120 hours) phases of Cycle 1.
Total Control Rate During Acute, Delayed, and Overall Phases of Cycle 1
Proportion of participants with no vomiting, no rescue antiemetic medication use, and no nausea (VAS score \<5 mm) during the acute, delayed, and overall phases of Cycle 1.
Appetite Loss Severity
Appetite loss assessed daily using a 4-point Likert scale (0-3). Changes from baseline and average appetite loss scores during the overall phase will be evaluated.
Number of Participants With Abnormal Laboratory Values and Adverse Events That Are Related to Treatment
Incidence and severity of auricular acupressure-related adverse events, chemotherapy-related adverse events, vital sign abnormalities, and laboratory abnormalities assessed according to NCI-CTCAE version 5.0.
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China Medical University, China
Lead sponsor
First Hospital of China Medical University
Sponsor institution
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