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

NCT07760766 | Not Yet Recruiting

• 1 other identifier: 2026-514-3
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Auricular Acupressure; Chemotherapy-Induced Nausea and Vomiting; CINV; Highly Emetogenic Chemotherapy; Integrative Oncology; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  Daily from Day 1 to Day 5 after chemotherapy administration in Cycle 1 (each chemotherapy cycle is approximately 21-28 days).

Other Outcomes (1)

• Number of Participants With Abnormal Laboratory Values and Adverse Events That Are Related to Treatment

  From enrollment through completion of Cycle 4 chemotherapy (each chemotherapy cycle is approximately 21-28 days).

Study Arms (2)

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.

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

Other: Sham Auricular Acupressure

Interventions

Auricular Acupressure OTHER

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

Auricular Acupressure Group

Sham Auricular Acupressure OTHER

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.

Sham Auricular Acupressure Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Related Publications (3)

• 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.

  PMID: 41369283 BACKGROUND

• Zhang 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.

  PMID: 28854065 BACKGROUND

• Shen 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.

  PMID: 39241208 BACKGROUND

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• xiujuan Qu, MD, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiujuan Qu, MD, PhD

CONTACT

15040271175; 435609433@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, outcome assessors, data managers, and statisticians will remain blinded to treatment allocation throughout the study. Only trained traditional Chinese medicine (TCM) physicians administering the interventions will know treatment assignments and will not be involved in outcome assessment, data management, or statistical analysis. Active and sham auricular acupressure will use identical Vaccaria seed ear patches and treatment schedules. Participants in both groups will receive identical instructions regarding self-acupressure procedures and frequency. Allocation codes will be maintained by an independent statistician until completion of the final analysis unless unblinding is required for participant safety.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

CN (1)