Chemotherapy-induced Nausea and VomitingAACINVNCT07760766
Auricular Acupressure for Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
A study testing Auricular Acupressure in people with Chemotherapy-induced Nausea and Vomiting, run by China Medical University, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Auricular Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
xiujuan Qu, MD, PhD, 15040271175, 435609433@qq.com
xiujuan Qu, MD, PhD
About this study
Official title: Effect of Auricular Acupressure Added to Standard Triple Antiemetic Therapy for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Multicenter Randomized Double-Blind Sham-Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Auricular Acupressure, Sham Auricular Acupressure
- Keywords
- Auricular Acupressure, Chemotherapy-Induced Nausea and Vomiting, CINV, Highly Emetogenic Chemotherapy, Integrative Oncology, Randomized Controlled Trial
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureOther
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 AcupressureOther
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 group | Role | What they receive |
|---|---|---|
| Auricular Acupressure Group | Experimental | 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. Receives: Other: Auricular Acupressure |
| Sham Auricular Acupressure Group | Sham comparator | 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 Receives: Other: Sham Auricular Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 to 120 hours after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily from Day 1 to Day 5 after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujuan Qu, First Hospital of China Medical University
- Investigators
- xiujuan Qu, MD, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760766
- Sponsor's protocol ID
- 2026-514-3
- Other IDs
- 2026-514-3
- Acronym
- AACINV
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shen MY, Li ZJ, Zhou R, Lou QY, Ying ZK, Liu S, Feng DD, Yang DD, Jiang LX, Wang XL, Wu JX, Li M, Wu JN. Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Dec 10. doi: 10.14309/ajg.0000000000003880. Online ahead of print.
PubMed 41369283Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.
PubMed 28854065Shen 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.
PubMed 39241208
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Auricular Acupressure Added to Standard Triple Antiemetic Therapy for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Multicenter Randomized Double-Blind Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07760766
- Acronym / sponsor ID
- AACINV / 2026-514-3
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Auricular Acupressure, Chemotherapy-Induced Nausea and Vomiting, CINV, Highly Emetogenic Chemotherapy, Integrative Oncology, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure Group | Experimental | Other: Auricular AcupressureParticipants 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. |
| Sham Auricular Acupressure Group | Sham comparator | Other: Sham Auricular AcupressureParticipants 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years, either sex.
- ③ Chemotherapy-naïve, planned to receive a single-day intravenous highly emetogenic chemotherapy (HEC) regimen, including:
- 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.
Key exclusion criteria (8 listed)
- Nausea or vomiting already present within 24 hours prior to enrollment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupressureAuricular 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 | Other | Auricular Acupressure Group |
| Sham Auricular AcupressureSham 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. | Other | Sham Auricular Acupressure Group |
Primary outcome
Complete Protection (CP) Rate During the Delayed Phase of Cycle 1
Time frame: 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.
4 secondary outcomes
Complete Protection Rate During the Acute and Overall Phases of Cycle 1
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
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
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
Time frame: Daily from Day 1 to Day 5 after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 41369283Shen MY, Li ZJ, Zhou R, Lou QY, Ying ZK, Liu S, Feng DD, Yang DD, Jiang LX, Wang XL, Wu JX, Li M, Wu JN. Efficacy and Safety of Auricular Acupressure for Insomnia in Patients With Functional Dyspepsia: A Randomized Controlled Trial. Am J Gastroenterol. 2025 Dec 10. doi: 10.14309/ajg.0000000000003880. Online ahead of print.
- Background: PubMed 28854065Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.
- Background: PubMed 39241208Shen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
xiujuan Qu, MD, PhD principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure in people with Chemotherapy-induced Nausea and Vomiting, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiujuan Qu, MD, PhD (15040271175, 435609433@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Protection (CP) Rate During the Delayed Phase of Cycle 1 (time frame: 24 to 120 hours after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07760766, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.