Nausea and Vomiting Caused by Trastuzumab DeruxtecanPhase 2ADTDNCT07537673
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan
A Phase 2 study testing Auricular point stimulation plus dexamethasone in people with Nausea and Vomiting Caused by Trastuzumab Deruxtecan, 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 trastuzumab deruxtecan in breast cancer palliative therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nausea and Vomiting Caused by Trastuzumab Deruxtecan
- 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;
- Breast cancer patients scheduled to undergo palliative treatment with trastuzumab deruxtecan;
- 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 Trastuzumab Deruxtecan in Breast Cancer Palliative Therapy
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 trastuzumab deruxtecan in breast cancer palliative therapy. 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 trastuzumab deruxtecan? 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 trastuzumab deruxtecan treatment. Starting from the day of trastuzumab deruxtecan treatment (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
Trastuzumab deruxtecan is an important therapeutic agent in the palliative treatment of advanced breast cancer. It is used as first-line therapy for HER2-positive advanced breast cancer in patients who have previously received anti-HER2 treatment, as well as second-line or later therapy for advanced or recurrent breast cancer. Additionally, it is the first targeted therapy approved in China for HER2-low advanced breast cancer. While it improves patient survival rates, it is also associated with certain gastrointestinal adverse reactions, with treatment-related nausea and vomiting being particularly common, occurring in nearly 80% of cases. The majority of these symptoms occur on the day of administration and within the following four days. This regimen is currently classified as a high emetic risk treatment in clinical guidelines. The recommended prophylactic antiemetic strategy typically involves a quadruple regimen combining corticosteroids (e.g., dexamethasone), 5-HT3 receptor antagonists (e.g., ondansetron, palonosetron), NK1 receptor antagonists (e.g., fosaprepitant, aprepitant), and the antipsychotic drug olanzapine. However, in clinical practice, many patients experience drug-related gastrointestinal adverse reactions such as anorexia, bloating, constipation, and diarrhea due to the use of high-intensity antiemetic therapy. Studies have shown that the incidence of constipation in chemotherapy patients treated with palonosetron nearly doubles. The aggressive use of antiemetics severely impacts patients' gastrointestinal function, quality of life, and even their treatment adherence. Therefore, how to effectively prevent trastuzumab deruxtecan -induced nausea and vomiting while minimizing the side effects of antiemetic therapy itself has become a practical issue that healthcare professionals urgently need to address.
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 anti-cancer therapy-related nausea and vomiting 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 trastuzumab deruxtecan. 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 theoretical and practical foundation described above, this study aims to evaluate the efficacy and safety of auricular point pressing with beans combined with dexamethasone in preventing and suppressing nausea and vomiting induced by trastuzumab deruxtecan in the palliative treatment of breast cancer. It will also assess patient appetite, gastrointestinal function, and other related indicators, exploring the important role of integrated traditional Chinese and Western medicine interventions in improving the quality of life of patients during antitumor therapy. The findings are expected to provide clinical references for optimizing the management of adverse reactions associated with trastuzumab deruxtecan.
- 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 trastuzumab deruxtecan treatment (d1): 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 (d1) to the following five days (d1-d5): 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 trastuzumab deruxtecan for breast cancer palliative therapy, 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 trastuzumab deruxtecan treatment (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 trastuzumab deruxtecan treatment (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 trastuzumab deruxtecan treatment (Day 1) until the end of Day 5
Proportion of patients requiring additional antiemetics
Measured: from the day of trastuzumab deruxtecan treatment (Day 1) until the end of 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 Trastuzumab DeruxtecanStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537673
- Sponsor's protocol ID
- 20251807
- Acronym
- ADTD
- Status last verified
- Nov 2025
- First submitted
- 14 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
Stankowicz M, Mauro L, Harnden K, Pennisi A. Management of Chemotherapy-Induced Nausea and Vomiting with Trastuzumab Deruxtecan: A Case Series. Breast Care (Basel). 2021 Aug;16(4):408-411. doi: 10.1159/000511049. Epub 2020 Oct 23.
PubMed 34602948
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 Trastuzumab Deruxtecan in Breast Cancer Palliative Therapy
- ClinicalTrials.gov ID
- NCT07537673
- Acronym / sponsor ID
- ADTD / 20251807
- 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 trastuzumab deruxtecan in breast cancer palliative therapy. 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 trastuzumab deruxtecan? 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 trastuzumab deruxtecan treatment. Starting from the day of trastuzumab deruxtecan treatment (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
Trastuzumab deruxtecan is an important therapeutic agent in the palliative treatment of advanced breast cancer. It is used as first-line therapy for HER2-positive advanced breast cancer in patients who have previously received anti-HER2 treatment, as well as second-line or later therapy for advanced or recurrent breast cancer. Additionally, it is the first targeted therapy approved in China for HER2-low advanced breast cancer. While it improves patient survival rates, it is also associated with certain gastrointestinal adverse reactions, with treatment-related nausea and vomiting being particularly common, occurring in nearly 80% of cases. The majority of these symptoms occur on the day of administration and within the following four days. This regimen is currently classified as a high emetic risk treatment in clinical guidelines. The recommended prophylactic antiemetic strategy typically involves a quadruple regimen combining corticosteroids (e.g., dexamethasone), 5-HT3 receptor antagonists (e.g., ondansetron, palonosetron), NK1 receptor antagonists (e.g., fosaprepitant, aprepitant), and the antipsychotic drug olanzapine. However, in clinical practice, many patients experience drug-related gastrointestinal adverse reactions such as anorexia, bloating, constipation, and diarrhea due to the use of high-intensity antiemetic therapy. Studies have shown that the incidence of constipation in chemotherapy patients treated with palonosetron nearly doubles. The aggressive use of antiemetics severely impacts patients' gastrointestinal function, quality of life, and even their treatment adherence. Therefore, how to effectively prevent trastuzumab deruxtecan -induced nausea and vomiting while minimizing the side effects of antiemetic therapy itself has become a practical issue that healthcare professionals urgently need to address.
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 anti-cancer therapy-related nausea and vomiting 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 trastuzumab deruxtecan. 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 theoretical and practical foundation described above, this study aims to evaluate the efficacy and safety of auricular point pressing with beans combined with dexamethasone in preventing and suppressing nausea and vomiting induced by trastuzumab deruxtecan in the palliative treatment of breast cancer. It will also assess patient appetite, gastrointestinal function, and other related indicators, exploring the important role of integrated traditional Chinese and Western medicine interventions in improving the quality of life of patients during antitumor therapy. The findings are expected to provide clinical references for optimizing the management of adverse reactions associated with trastuzumab deruxtecan.
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 trastuzumab deruxtecan for breast cancer palliative therapy, 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 trastuzumab deruxtecan treatment (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 trastuzumab deruxtecan treatment (d1): 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 (d1) to the following five days (d1-d5): 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 trastuzumab deruxtecan treatment (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 trastuzumab deruxtecan treatment (Day 1) until the end of Day 5
Proportion of patients requiring additional antiemetics
Time frame: from the day of trastuzumab deruxtecan treatment (Day 1) until the end of 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: PubMed 34602948Stankowicz M, Mauro L, Harnden K, Pennisi A. Management of Chemotherapy-Induced Nausea and Vomiting with Trastuzumab Deruxtecan: A Case Series. Breast Care (Basel). 2021 Aug;16(4):408-411. doi: 10.1159/000511049. Epub 2020 Oct 23.
- 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.
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 Trastuzumab Deruxtecan, 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 trastuzumab deruxtecan treatment (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 NCT07537673, 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.