Nausea and Vomiting Caused by ChemotherapyPhase 2ADDCNCT07537699
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide
A Phase 2 study testing Auricular point stimulation plus dexamethasone 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
The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2025to Nov 2026
- Phase
- Phase 2
- 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
Inclusion Criteria: 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.
Exclusion Criteria: 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 for Nausea and Vomiting Caused by Docetaxel Combined With Cyclophosphamide in Breast Cancer Adjuvant Chemotherapy
The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone.
The main questions it aims to answer are:
Read more
Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs?
Participants 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.
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 the efficacy and safety of auricular point pressotherapy combined with dexamethasone for CINV induced by docetaxel plus cyclophosphamide in postoperative adjuvant chemotherapy for breast cancer. At the same time, it will assess related indicators such as patients' appetite and gastrointestinal function, and explore the important role of integrated traditional Chinese and Western medicine intervention in improving patients' quality of life during chemotherapy, to provide clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen.
- Being tested
- Auricular point stimulation plus dexamethasone
- 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 dexamethasoneOther
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, noon, and 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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular point stimulation plus dexamethasone 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: Other: Auricular point stimulation plus dexamethasone |
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 posted17 Apr 2026
- Study start25 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- 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
- NCT07537699
- Sponsor's protocol ID
- 20251806
- Acronym
- ADDC
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] JONES S E, SAVIN M A, HOLMES F A, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. Journal of clinical oncology, 2006, 24: 5381-7. [2] LLOMBART-CUSSAC A, RAMOS M, DALMAU E, et al. 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. European journal of cancer, 2016, 58: 122-9. [3] KIMURA S, HOSOYA K, OGATA K, et al. Severity of constipation related to palonosetron during first-line chemotherapy: a retrospective observational study. Support Care Cancer, 2021, 29: 4723-32.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Combined With Cyclophosphamide in Breast Cancer Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07537699
- Acronym / sponsor ID
- ADDC / 20251806
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Apr 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.
The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone.
The main questions it aims to answer are:
Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs?
Participants 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.
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 the efficacy and safety of auricular point pressotherapy combined with dexamethasone for CINV induced by docetaxel plus cyclophosphamide in postoperative adjuvant chemotherapy for breast cancer. At the same time, it will assess related indicators such as patients' appetite and gastrointestinal function, and explore the important role of integrated traditional Chinese and Western medicine intervention in improving patients' quality of life during chemotherapy, to provide clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auricular point stimulation plus dexamethasone group | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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, noon, and 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. | Other | Auricular point stimulation plus dexamethasone 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 17 Apr 2026.
- Background[1] JONES S E, SAVIN M A, HOLMES F A, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. Journal of clinical oncology, 2006, 24: 5381-7. [2] LLOMBART-CUSSAC A, RAMOS M, DALMAU E, et al. 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. European journal of cancer, 2016, 58: 122-9. [3] KIMURA S, HOSOYA K, OGATA K, et al. Severity of constipation related to palonosetron during first-line chemotherapy: a retrospective observational study. Support Care Cancer, 2021, 29: 4723-32.
- Individual participant dataSharing planned: No
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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.
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 2 study testing Auricular point stimulation plus dexamethasone 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?
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 17 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT07537699, which also lists 1 linked publication.
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 17 Apr 2026.