An interventional study of Auricular Acupressure and Sham Auricular Acupressure in Chemotherapy-induced Nausea and Vomiting, sponsored by China Medical University, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by China Medical University, China · Not applicable, Interventional, and Prevention
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.
Chemotherapy-induced nausea and vomiting (CINV) remains one of the most common and distressing adverse effects experienced by patients receiving systemic anticancer therapy. Despite substantial advances in antiemetic prophylaxis, CINV continues to negatively affect nutritional status, treatment adherence, daily functioning, psychological well-being, and health-related quality of life. Patients receiving highly emetogenic chemotherapy (HEC), including anthracycline-cyclophosphamide-based regimens and cisplatin-containing regimens, remain at particularly high risk for both acute and delayed CINV.
Current international antiemetic guidelines recommend prophylactic antiemetic therapy consisting of a neurokinin-1 receptor antagonist, a 5-hydroxytryptamine-3 receptor antagonist, and dexamethasone for patients receiving HEC. Although guideline-recommended regimens have substantially improved emesis control, delayed-phase CINV (24-120 hours after chemotherapy) remains insufficiently controlled in a considerable proportion of patients. Delayed nausea is particularly challenging to manage and is frequently associated with impaired oral intake, reduced quality of life, increased healthcare utilization, and decreased willingness to continue planned anticancer treatment. Therefore, the identification of effective adjunctive interventions for improving delayed-phase CINV control remains an important unmet clinical need.
Auricular acupressure is a noninvasive intervention derived from traditional Chinese medicine. Through continuous stimulation of specific auricular acupoints, auricular acupressure may influence autonomic nervous system activity, gastrointestinal function, neuroendocrine regulation, and symptom perception. Auricular acupoint stimulation has been investigated as a complementary approach for the prevention and management of chemotherapy-induced nausea and vomiting in patients receiving anticancer treatment.
Previous clinical studies and systematic reviews have suggested that auricular acupressure may improve chemotherapy-related nausea and vomiting and reduce symptom burden in patients with cancer. However, the currently available evidence remains limited by methodological heterogeneity, small sample sizes, inadequate sham-control procedures, insufficient blinding, and inconsistent outcome assessment methods. In particular, relatively few rigorously designed randomized controlled trials have specifically focused on delayed-phase CINV, which remains one of the most difficult aspects of antiemetic management. Consequently, high-quality evidence regarding the efficacy and safety of auricular acupressure as an adjunct to contemporary guideline-based antiemetic prophylaxis remains insufficient.
The auricular acupoint prescription used in this study was developed in accordance with the auricular acupoint recommendations described in the 2025 Chinese Society of Clinical Oncology (CSCO) Guideline for the Prevention and Treatment of Antitumor Therapy-Induced Nausea and Vomiting. The intervention includes auricular acupoints such as Shenmen, Stomach, Sympathetic, and other protocol-specified points selected for the management of chemotherapy-induced nausea and vomiting.
This study is designed as a multicenter, randomized, double-blind, sham-controlled clinical trial to evaluate the efficacy and safety of auricular acupressure as an adjunct to standard triple antiemetic therapy in patients receiving highly emetogenic chemotherapy. Eligible participants will be randomly assigned in a 1:1 ratio to receive either active auricular acupressure or sham auricular acupressure in addition to guideline-recommended antiemetic prophylaxis. The sham-controlled design is intended to minimize expectation bias and improve the internal validity of the study.
The primary objective of this trial is to determine whether auricular acupressure improves delayed-phase control of chemotherapy-induced nausea and vomiting during the first cycle of highly emetogenic chemotherapy. The primary endpoint is the complete protection (CP) rate during the delayed phase (24-120 hours after chemotherapy), defined as no vomiting, no use of rescue antiemetic medication, and a nausea visual analogue scale (VAS) score below 25 mm. Compared with conventional endpoints that primarily focus on emesis control, complete protection incorporates both nausea severity and rescue medication use, thereby providing a more comprehensive assessment of clinically meaningful symptom control.
Secondary objectives include the evaluation of complete protection, complete response, total control, nausea severity, vomiting outcomes, rescue medication use, appetite changes, patient-reported outcomes, health-related quality of life, treatment adherence, and safety outcomes across multiple chemotherapy cycles. Validated patient-reported outcome instruments, including the Functional Living Index-Emesis (FLIE) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), will be used to comprehensively assess symptom burden, functional impact, and quality of life.
By employing a multicenter design, rigorous randomization procedures, double blinding, standardized intervention protocols, guideline-based antiemetic therapy, and validated outcome measures, this study seeks to address important limitations of previous research and generate robust clinical evidence regarding the effectiveness and safety of auricular acupressure for the prevention of chemotherapy-induced nausea and vomiting. The findings of this trial are expected to contribute to the evidence base for integrative symptom management and support the optimization of CINV prevention strategies in patients receiving highly emetogenic chemotherapy.
793 studies on the registry are indexed under Vomiting; 99 are open to participants now.
This study's planned enrollment of 332 is above the median of 103 across 673 interventional studies indexed under Vomiting.
Browse Vomiting studies →China Medical University, China is the lead sponsor of 94 studies on the registry; 34 are open to participants now.
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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:
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 performance status score 0-1.
⑥ ≥ 6 months.
⑦ Voluntarily signed , and able to understand and complete the patient diary.
Exclusion Criteria
Nausea or vomiting already present within 24 hours prior to enrollment.
Symptomatic , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive active auricular acupressure in addition to guideline-recommended triple antiemetic prophylaxis during highly emetogenic chemotherapy. 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 throughout the intervention period.
Other: Auricular Acupressure
Participants assigned to this arm will receive sham auricular acupressure in addition to guideline-recommended triple antiemetic prophylaxis during highly emetogenic chemotherapy. Vaccaria seed ear patches identical in appearance to those used in the active intervention will be applied to non-therapeutic auricular points located in the earlobe area. Participants will receive the same instructions regarding self-acupressure procedures and frequency as those in the active intervention group
Other: Sham 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 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.
Time frame: 24 to 120 hours after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).
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).
Time frame: 0-24 hours and 0-120 hours after chemotherapy administration in Cycle 1(each chemotherapy cycle is approximately 21-28 days).
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.
Time frame: 0-120 hours after chemotherapy administration in Cycle 1, including acute phase (0-24 hours), delayed phase (24-120 hours), and overall phase (0-120 hours) (each chemotherapy cycle is approximately 21-28 days).
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.
Time frame: 0-120 hours after chemotherapy administration in Cycle 1, including acute phase (0-24 hours), delayed phase (24-120 hours), and overall phase (0-120 hours) (each chemotherapy cycle is approximately 21-28 days).
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.
Time frame: Daily from Day 1 to Day 5 after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).
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.
Time frame: From enrollment through completion of Cycle 4 chemotherapy (each chemotherapy cycle is approximately 21-28 days).
Plan to share: Undecided
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China Medical University, China