Nausea and Vomiting Caused by ChemotherapyPhase 3ADDC ⅡNCT07716176
Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide
A Phase 3 study testing Auricular point stimulation plus dexamethasone and Standard pharmacologic antiemetic regimen in people with Nausea and Vomiting Caused by Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nausea and Vomiting Caused by Chemotherapy
- What is being tested?
- Auricular point stimulation plus dexamethasone and Standard pharmacologic antiemetic regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 12 Dec 2026
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following inclusion criteria for the study:* Age ≥ 18 years and ≤ 85 years* After a radical mastectomy, further postoperative adjuvant chemotherapy with docetaxel combined with cyclophosphamide regimen is required.* ECOG performance status score of 0-2.* Normal hematological function (platelet count > 80×10⁹/L; white blood cell count > 3×10⁹/L; neutrophil count > 1.5×10⁹/L).* Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), and transaminase ≤ 5 times the ULN.* No ascites, no gastrointestinal obstruction, normal coagulation function, and serum albumin ≥ 30g/L.* Child-Pugh classification of liver function is Grade A.* Serum creatinine < ULN, or calculated creatinine clearance rate > 50ml/min.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Juan Wang, 8617816190946, wangjuan.happy@hotmail.com
About this study
Official title: Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Combined With Cyclophosphamide in Breast Cancer Adjuvant Chemotherapy
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.
Read the detailed description
Docetaxel combined with cyclophosphamide is one of the most commonly used chemotherapy regimens for postoperative adjuvant treatment of breast cancer. While it improves patients' survival rate, it is accompanied by certain gastrointestinal adverse reactions, among which chemotherapy-induced nausea and vomiting (CINV) is relatively common, with an incidence rate ranging from 16% to 54%. The vast majority of cases occur on the day of medication and within 4 days thereafter. This regimen is defined as a chemotherapy regimen with low to moderate emetogenic risk in current clinical guidelines. The recommended preventive antiemetic strategy usually consists of glucocorticoids (e.g., dexamethasone) combined with 5-HT3 receptor antagonists (e.g., ondansetron, palonosetron, etc.). It can be strengthened with NK1 receptor antagonists (e.g., fosaprepitant, aprepitant) and the antipsychotic olanzapine, depending on clinical circumstances. However, in clinical practice, many patients experience drug-related gastrointestinal adverse reactions such as anorexia, abdominal distension, constipation, and diarrhea due to receiving high-intensity antiemetic therapy. Studies have shown that the incidence of constipation in chemotherapy patients treated with palonosetron approximately doubles. The high-intensity use of antiemetic drugs seriously impairs patients' gastrointestinal function and quality of life, and even affects their treatment compliance. Therefore, how to effectively prevent CINV while minimizing the side effects caused by antiemetic therapy itself has become a practical issue that medical staff need to pay urgent attention to. Auricular point pressotherapy is a traditional Chinese medicine (TCM) external therapy. It involves accurately pasting Vaccaria seeds on corresponding auricular points with adhesive tapes and stimulating the points through moderate pressing to regulate physical functions and treat diseases. According to TCM theory, the ear is closely connected to the internal organs and meridians of the human body, and all twelve meridians are directly or indirectly linked to the ear. Auricular point pressotherapy can unblock meridians and balance yin and yang by stimulating corresponding auricular points, thereby alleviating CINV and other adverse reactions. It is an economical, non-invasive, and low-side-effect natural therapy. Meanwhile, auricular point pressotherapy can effectively improve gastrointestinal function, thus significantly reducing gastrointestinal dysfunction caused by chemotherapy and antiemetic drugs, such as anorexia, abdominal distension, constipation, and diarrhea. Our team summarized the relevant data of patients who voluntarily received auricular point pressotherapy for antiemesis previously. The results showed that among breast cancer patients who received docetaxel combined with cyclophosphamide for postoperative adjuvant chemotherapy, 100% of those treated with auricular point pressotherapy plus dexamethasone did not experience grade 2 or above (including grade 2) nausea and had no vomiting on the day of medication and within 3 days thereafter.
Based on the above theoretical and practical basis, this study intends to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on the CINV 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.
- Being tested
- Auricular point stimulation plus dexamethasone, Standard pharmacologic antiemetic regimen
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular point stimulation plus dexamethasoneDrug
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.
Standard pharmacologic antiemetic regimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard pharmacologic antiemetic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants will be asked to fill out a questionnaire to record whether vomiting occurs. If vomiting occurs, its grade according to the NIC-CTC AE4.0 should be recorded.
Measured: from the day of chemotherapy (Day 1) until the end of Day 5
Proportion of patients requiring additional antiemetics
Measured: from the day of chemotherapy (Day 1) until Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start12 Dec 2025
- Primary completion6 Dec 2026 (estimated)
- Study completion12 Dec 2026 (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 Nausea and Vomiting Caused by ChemotherapyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Wang, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716176
- Sponsor's protocol ID
- 20251945
- Acronym
- ADDC Ⅱ
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33515108Llombart-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.
PubMed 26994459Jones 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.
PubMed 17135639
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Combined With Cyclophosphamide in Breast Cancer Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07716176
- Acronym / sponsor ID
- ADDC Ⅱ / 20251945
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 6 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 21 Jul 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.
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.
Detailed description
Docetaxel combined with cyclophosphamide is one of the most commonly used chemotherapy regimens for postoperative adjuvant treatment of breast cancer. While it improves patients' survival rate, it is accompanied by certain gastrointestinal adverse reactions, among which chemotherapy-induced nausea and vomiting (CINV) is relatively common, with an incidence rate ranging from 16% to 54%. The vast majority of cases occur on the day of medication and within 4 days thereafter. This regimen is defined as a chemotherapy regimen with low to moderate emetogenic risk in current clinical guidelines. The recommended preventive antiemetic strategy usually consists of glucocorticoids (e.g., dexamethasone) combined with 5-HT3 receptor antagonists (e.g., ondansetron, palonosetron, etc.). It can be strengthened with NK1 receptor antagonists (e.g., fosaprepitant, aprepitant) and the antipsychotic olanzapine, depending on clinical circumstances. However, in clinical practice, many patients experience drug-related gastrointestinal adverse reactions such as anorexia, abdominal distension, constipation, and diarrhea due to receiving high-intensity antiemetic therapy. Studies have shown that the incidence of constipation in chemotherapy patients treated with palonosetron approximately doubles. The high-intensity use of antiemetic drugs seriously impairs patients' gastrointestinal function and quality of life, and even affects their treatment compliance. Therefore, how to effectively prevent CINV while minimizing the side effects caused by antiemetic therapy itself has become a practical issue that medical staff need to pay urgent attention to. Auricular point pressotherapy is a traditional Chinese medicine (TCM) external therapy. It involves accurately pasting Vaccaria seeds on corresponding auricular points with adhesive tapes and stimulating the points through moderate pressing to regulate physical functions and treat diseases. According to TCM theory, the ear is closely connected to the internal organs and meridians of the human body, and all twelve meridians are directly or indirectly linked to the ear. Auricular point pressotherapy can unblock meridians and balance yin and yang by stimulating corresponding auricular points, thereby alleviating CINV and other adverse reactions. It is an economical, non-invasive, and low-side-effect natural therapy. Meanwhile, auricular point pressotherapy can effectively improve gastrointestinal function, thus significantly reducing gastrointestinal dysfunction caused by chemotherapy and antiemetic drugs, such as anorexia, abdominal distension, constipation, and diarrhea. Our team summarized the relevant data of patients who voluntarily received auricular point pressotherapy for antiemesis previously. The results showed that among breast cancer patients who received docetaxel combined with cyclophosphamide for postoperative adjuvant chemotherapy, 100% of those treated with auricular point pressotherapy plus dexamethasone did not experience grade 2 or above (including grade 2) nausea and had no vomiting on the day of medication and within 3 days thereafter.
Based on the above theoretical and practical basis, this study intends to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on the CINV 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular point stimulation group | Experimental | Drug: Auricular point stimulation plus dexamethasoneFor 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. |
| Standard pharmacologic antiemetic regimen group | Active comparator | Drug: Standard pharmacologic antiemetic regimenPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must meet the following inclusion criteria for the study:* Age ≥ 18 years and ≤ 85 years* After a radical mastectomy, further postoperative adjuvant chemotherapy with docetaxel combined with cyclophosphamide regimen is required.* ECOG performance status score of 0-2.* Normal hematological function (platelet count > 80×10⁹/L; white blood cell count > 3×10⁹/L; neutrophil count > 1.5×10⁹/L).* Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), and transaminase ≤ 5 times the ULN.* No ascites, no gastrointestinal obstruction, normal coagulation function, and serum albumin ≥ 30g/L.* Child-Pugh classification of liver function is Grade A.* Serum creatinine < ULN, or calculated creatinine clearance rate > 50ml/min.
Key exclusion criteria (1 listed)
- 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.
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 point stimulation plus dexamethasoneOn 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. | Drug | Auricular point stimulation group |
| Standard pharmacologic antiemetic regimenReceive 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. | Drug | Standard pharmacologic antiemetic regimen group |
Primary outcome
Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0
Time frame: from the day of chemotherapy (Day 1) until the end of Day 5
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.
2 secondary outcomes
Proportion of patients experiencing vomiting as assessed by NIC-CTC AE4.0
Time frame: from the day of chemotherapy (Day 1) until the end of Day 5
Proportion of patients requiring additional antiemetics
Time frame: from the day of chemotherapy (Day 1) until Day 5
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 21 Jul 2026.
- Background: PubMed 33515108Kimura 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.
- Background: PubMed 26994459Llombart-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.
- Background: PubMed 17135639Jones 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.
Related trials for Nausea and Vomiting Caused by Chemotherapy
RecruitingPhase 3
Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein-bound
Nausea and Vomiting Caused by Chemotherapy
RecruitingPhase 2
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Plus Paclitaxel
Nausea and Vomiting Caused by Chemotherapy
RecruitingPhase 2
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide
Nausea and Vomiting Caused by Chemotherapy
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.
Juan Wang study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Auricular point stimulation plus dexamethasone and Standard pharmacologic antiemetic regimen in people with Nausea and Vomiting Caused by Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Juan Wang (8617816190946, wangjuan.happy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0 (time frame: from the day of chemotherapy (Day 1) until the end of Day 5). 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 NCT07716176, 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 21 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.