Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide

NCT07716176 | Recruiting Phase 3

• 1 other identifier: 20251945
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen are non-inferior to the standard antiemetic regimen. Additionally, it will assess patients' appetite, gastrointestinal function, and other related indicators, and explore the significant role of integrated traditional Chinese medicine and Western medicine interventions in improving patients' quality of life during chemotherapy, thereby providing a clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen. The main questions it aims to answer are: Whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen are non-inferior to the standard antiemetic regimen? In comparison with a standard pharmacologic antiemetic regimen, does auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions? Breast cancer patients receiving adjuvant chemotherapy with the docetaxel plus cyclophosphamide regimen after surgery will be randomly assigned in a 1:1 ratio to either the auricular point stimulation group or the standard pharmacologic antiemetic regimen group. Patients in the auricular point stimulation group will: Receive auricular acupressure with bean seeds on specific points of one ear, plus intravenous injection of dexamethasone as a preventive antiemetic treatment within half an hour before chemotherapy. Starting from the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5), provide regular stimulation at the acupressure points daily by themselves according to the protocol provided in this trial. Record their nausea and vomiting status, appetite, and gastrointestinal function-related symptomatic indicators from Day 1 to Day 5. Oral antiemetics are also prepared. If nausea and vomiting are significant or the patient feels the need, they may be temporarily administered as an adjunct. Patients in the standard pharmacologic antiemetic regimen group will: Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines.

Conditions

Nausea and Vomiting Caused by Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0

  Participants will be asked to fill out a questionnaire to record whether nausea occurs. If nausea occurs, its grade according to the NIC-CTC AE4.0 should be recorded.

  from the day of chemotherapy (Day 1) until the end of Day 5

Secondary Outcomes (2)

• Proportion of patients experiencing vomiting as assessed by NIC-CTC AE4.0

  from the day of chemotherapy (Day 1) until the end of Day 5

• Proportion of patients requiring additional antiemetics

  from the day of chemotherapy (Day 1) until Day 5

Other Outcomes (1)

• Proportion of patients experiencing chemotherapy-related adverse events as assessed by CTCAE v4.0

  from the day of chemotherapy (Day 1) until Day 5

Study Arms (2)

Auricular point stimulation group

EXPERIMENTAL

For breast cancer patients who will receive docetaxel combined with cyclophosphamide for postoperative adjuvant chemotherapy, preventive antiemetic treatment consisting of unilateral auricular point stimulation at specific acupoints and dexamethasone will be administered within 30 minutes before chemotherapy. Auricular acupoint stimulation is performed by adhering Vaccaria seeds to specific points with adhesive tape and applying moderate pressure until a certain level of soreness is elicited. Vaccaria seeds are kept on the ear from the day of chemotherapy (Day 1) until the end of Day 5.

Drug: Auricular point stimulation plus dexamethasone

Standard pharmacologic antiemetic regimen group

ACTIVE COMPARATOR

Patients in the standard pharmacologic antiemetic regimen group will receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines and patients' actual conditions.

Drug: Standard pharmacologic antiemetic regimen

Interventions

Standard pharmacologic antiemetic regimen DRUG

Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines and patients' actual conditions, including dexamethasone ± 5-HT3 receptor inhibitor ± NK1 receptor inhibitor ± Olanzapine.

Standard pharmacologic antiemetic regimen group

Auricular point stimulation plus dexamethasone DRUG

On the day of chemotherapy (Day 1): within half an hour before chemotherapy, administer auricular acupressure on one ear (stimulating the stomach, cardia, and brainstem acupoints for 5 minutes each) along with an intravenous push of 5 mg dexamethasone. From the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5): Stimulate each acupoint once in the morning, at noon, and in the evening, for 5 minutes each time. If nausea or vomiting occurs, immediately apply additional stimulation for 5 minutes as a temporary measure. Oral antiemetics should be prepared and may be used temporarily if nausea and vomiting are significant and the patient feels the need.

Auricular point stimulation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study: \* Local inflammation or infection of the auricle\* Bleeding tendency or coagulation disorders\* Severe ascites\* Gastrointestinal obstruction\* Hypertensive crisis or hypertensive encephalopathy\* Severe uncontrolled systemic complications such as infection or diabetes mellitus\* Clinically severe cardiovascular diseases, including cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), hypertension that is not well-controlled despite appropriate medication, unstable angina pectoris, congestive heart failure (NYHA Class 2-4), and cardiac arrhythmias requiring drug treatment\* A history of or physical examination findings indicating central nervous system diseases (e.g., primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastasis or stroke)\* Hypersensitivity to any drugs used in the study\* Pregnant or lactating women\* Presence of any other diseases, functional impairment caused by metastatic lesions, or suspicious disorders identified during physical examination, which suggest contraindications to the study drugs or place the patient at high risk of treatment-related complications\* Inability or unwillingness to comply with the study protocol.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Related Publications (3)

• Kimura S, Hosoya K, Ogata K, Furuno T, Sogawa R, Takeuchi K, Tasaki M, Kawaguchi A, Nishioka A, Sueoka-Aragane N, Noshiro H, Kuratomi Y, Yokoyama M, Noguchi M, Anzai K, Yamashita Y, Kimura S, Irie H. Severity of constipation related to palonosetron during first-line chemotherapy: a retrospective observational study. Support Care Cancer. 2021 Aug;29(8):4723-4732. doi: 10.1007/s00520-021-06023-0. Epub 2021 Jan 29.

  PMID: 33515108 BACKGROUND

• Llombart-Cussac A, Ramos M, Dalmau E, Garcia-Saenz JA, Gonzalez-Farre X, Murillo L, Calvo L, Morales S, Caranana V, Gonzalez A, Fernandez-Morales LA, Moreno F, Casas MI, Angulo Mdel M, Camara MC, Garcia-Mace AI, Carrasco E, Jara-Sanchez C. Incidence of chemotherapy-induced nausea and vomiting associated with docetaxel and cyclophosphamide in early breast cancer patients and aprepitant efficacy as salvage therapy. Results from the Spanish Breast Cancer Group/2009-02 study. Eur J Cancer. 2016 May;58:122-9. doi: 10.1016/j.ejca.2016.01.015. Epub 2016 Mar 17.

  PMID: 26994459 BACKGROUND

• Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. doi: 10.1200/JCO.2006.06.5391.

  PMID: 17135639 BACKGROUND

MeSH Terms

Conditions

Nausea

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Juan Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Juan Wang

CONTACT

8617816190946; wangjuan.happy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: July 21, 2026

Record last verified: 2025-12

Locations

CN (1)