Breast NeoplasmsPhase 2NCT07848984
Chinese Herbal Acupoint Application Combined With Triple Antiemetic Therapy for Prevention of Chemotherapy-Induced Nausea and Vomiting in Breast Cancer
A Phase 2 study testing Chinese Herbal Acupoint Application and Standard Triple Antiemetic Therapy in people with Breast Neoplasms, 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 whether Chinese herbal acupoint application, when added to standard three-drug anti-nausea treatment, can prevent nausea and vomiting caused by chemotherapy in people with breast cancer. The study will also evaluate the safety of the Chinese herbal acupoint application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Chinese Herbal Acupoint Application and Standard Triple Antiemetic Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of sex；
- Pathologically confirmed operable breast cancer with no prior systemic chemotherapy；
- Planned to receive one of the following highly emetogenic chemotherapy (HEC) regimens. HEC refers to chemotherapy regimens associated with an expected incidence of vomiting of >90% in the absence of prophylactic antiemetic treatment, including anthracycline/cyclophosphamide-based regimens (AC, TC, or EC) and carboplatin-containing regimens (e.g., TCbH, TCbHP)；
- Planned to receive triple antiemetic prophylaxis consisting of an NK-1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone. NK-1 receptor antagonists may include fosrolapitant, aprepitant, fosaprepitant, or other approved agents; 5-HT3 receptor antagonists may include palonosetron, ondansetron, or other approved agents；
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
- Considered by the treating physician to be physically able to undergo and comply with the acupoint application procedure；
- Adequate major organ function and bone marrow function。
Who cannot join
- Skin damage, ulceration, scarring, or severe infection at the intended application sites;
- Known history of severe allergy to any adhesive tape, patch materials, or herbal/other ingredients used in the study;
- Significant nausea (VAS ≥25 mm) within 24 hours before chemotherapy that, in the investigator's judgment, is not related to chemotherapy;
- Refractory vomiting due to non-chemotherapy-related causes, such as complete intestinal obstruction or severe vomiting caused by increased intracranial pressure secondary to brain metastases;
- Pregnancy or breastfeeding;
- Concomitant brain metastases, increased intracranial pressure, gastrointestinal obstruction, or other diseases that may cause nausea or vomiting;
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- Severe hepatic, renal, or cardiac dysfunction, or other serious underlying diseases that, in the investigator's judgment, make the participant unsuitable for the study;
- Planned abdominal or pelvic radiotherapy within 7 days before randomization or during Days 1-7 of chemotherapy;
- Use of antiemetic medications within 48 hours before chemotherapy, except for the routine prophylactic antiemetic regimen specified in the triple antiemetic therapy, or use of other medications that may affect the assessment of nausea or vomiting;
- Severe psychiatric illness or cognitive impairment that prevents the participant from understanding the nausea/vomiting assessment scales or - complying with the 4-6-hour acupoint application procedure;
- Inability to take oral medications;
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
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
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Fuming Qiu, 86+13858005908, qiufuming@zju.edu.cn
About this study
Official title: Efficacy and Safety of Chinese Herbal Acupoint Application Combined With Triple Antiemetic Therapy for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether Chinese herbal acupoint application, when added to standard three-drug anti-nausea treatment, can prevent nausea and vomiting caused by chemotherapy in people with breast cancer. The study will also evaluate the safety of the Chinese herbal acupoint application.
The main questions it aims to answer are:
Read more
- Does Chinese herbal acupoint application help participants have less nausea during the first 5 days after chemotherapy?
- Does it reduce vomiting and the need for additional anti-nausea medicine?
- Does it affect the impact of chemotherapy-related nausea and vomiting on daily life?
- What medical problems or side effects occur with the Chinese herbal acupoint application?
Researchers will compare Chinese herbal acupoint application with a sham application. Both groups will receive standard three-drug anti-nausea treatment. The sham application looks and feels similar to the herbal application but does not contain the active herbal ingredients.
Participants will:
- Receive one cycle of planned chemotherapy and standard three-drug anti-nausea treatment.
- Receive either the Chinese herbal acupoint application or sham application before chemotherapy. The application will be placed on selected acupuncture points for 4 to 6 hours.
- Record nausea, vomiting, and use of additional anti-nausea medicine during the first 5 days after chemotherapy.
- Complete a questionnaire about how nausea and vomiting affect daily life.
- Have safety follow-up for about 2 weeks after chemotherapy.
- Conditions
- Breast Neoplasms
- Being tested
- Chinese Herbal Acupoint Application, Sham Acupoint Application, Standard Triple Antiemetic Therapy
- Keywords
- Breast Neoplasms, Antiemetics, Nausea, Vomiting, Acupressure, Medicine, Chinese Traditional
- Medical subject headings
- Breast Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal Acupoint ApplicationOther
On Day 1, before chemotherapy, participants will receive Chinese herbal acupoint application in addition to standard triple antiemetic therapy. The herbal preparation consists of Ginger-processed Pinellia 90 g, Coptis Rhizome 30 g, Magnoliae Officinalis Cortex 120 g, Ginger-processed Caulis Bambusae in Taeniam 100 g, Evodia fruit 30 g, Dried Tangerine Peel 60 g, and clove flower bud 60 g. The herbs are mixed into powder. For each application, 50 g of herbal powder is mixed with 50 mL normal saline and 50 g medical petrolatum to form a paste. Approximately 1 cm-diameter herbal patches are prepared and applied to the Conception Vessel 12 (CV12), Conception Vessel 8 (CV8), and bilateral Pericardium 6 (PC6) acupoints. The patches are removed after 4-6 hours.
Sham Acupoint ApplicationOther
On Day 1, before chemotherapy, participants will receive sham acupoint application in addition to standard triple antiemetic therapy. The sham patches will be identical to the herbal patches in appearance, size, matrix color, odor, and backing material. The sham matrix will contain petrolatum, medical adhesive, and starch, without any active herbal ingredients. The sham patches are not intended to exert pharmacological effects through the skin. The patches will be applied to the Conception Vessel 12 (CV12), Conception Vessel 8 (CV8), and bilateral Pericardium 6 (PC6) acupoints and removed after 4-6 hours.
Standard Triple Antiemetic TherapyDrug
All participants will receive a standard triple antiemetic regimen consisting of an NK-1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone according to the study protocol and clinical practice. NK-1 receptor antagonists may include fosrolapitant, aprepitant, or fosaprepitant. 5-HT3 receptor antagonists may include palonosetron or ondansetron. The specific antiemetic agent and dosing regimen will be selected according to the chemotherapy regimen and the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Acupoint Application | Experimental | Participants will receive Chinese herbal acupoint application before chemotherapy on Day 1. The herbal paste contains Chinese herbal medicines and will be applied to the Conception Vessel 12 (CV12), Conception Vessel 8 (CV8), and bilateral Pericardium 6 (PC6) acupoints. The patch will remain in place for 4 to 6 hours and will then be removed. Participants will also receive standard three-drug antiemetic treatment as planned for their chemotherapy. Receives: Other: Chinese Herbal Acupoint Application; Drug: Standard Triple Antiemetic Therapy |
| Sham Acupoint Application | Sham comparator | Participants will receive a sham acupoint application before chemotherapy on Day 1. The sham patch will have the same appearance, size, color, smell, and base material as the herbal patch, but will not contain any of the active Chinese herbal ingredients. The sham patch will remain in place for 4 to 6 hours and will then be removed. Participants will also receive standard three-drug antiemetic treatment as planned for their chemotherapy. Receives: Other: Sham Acupoint Application; Drug: Standard Triple Antiemetic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With No Significant Nausea (NSN) During 0-120 Hours After Chemotherapy
No Significant Nausea (NSN) is defined as a nausea score consistently below 25 mm on a 100-mm visual analogue scale (VAS) throughout the 0-120-hour observation period after chemotherapy. The VAS ranges from 0 mm (no nausea) to 100 mm (worst imaginable nausea). The outcome measure is the proportion of participants who meet the criteria for NSN during the overall 0-120-hour observation period.
Measured: 0-120 hours after initiation of chemotherapy
Secondary outcomes (5)
Nausea Severity by VAS During Acute, Delayed, and Overall Periods
Nausea severity will be assessed using a 100-mm visual analogue scale (VAS), with 0 mm indicating no nausea and 100 mm indicating the worst imaginable nausea. The maximum and mean VAS scores will be compared between the intervention and control groups during the acute period (0-24 hours), delayed period (24-120 hours), and overall period (0-120 hours) after chemotherapy.
Measured: 0-120 hours after initiation of chemotherapy
Proportion of Participants With No Significant Nausea During Acute and Delayed Periods
The proportion of participants with no significant nausea (NSN) will be compared between the intervention and control groups during the acute period (0-24 hours) and delayed period (24-120 hours) after chemotherapy. NSN is defined as a nausea VAS score consistently below 25 mm throughout the corresponding observation period.
Measured: 0-120 hours after initiation of chemotherapy
Complete Response (CR) Rate During Acute, Delayed, and Overall Periods
The proportion of participants achieving complete response (CR) will be compared between the intervention and control groups during the acute period (0-24 hours), delayed period (24-120 hours), and overall period (0-120 hours) after chemotherapy. CR is defined as no vomiting and no use of rescue antiemetic medication during the corresponding observation period.
Measured: 0-120 hours after initiation of chemotherapy
Complete Control (CC) Rate During Acute, Delayed, and Overall Periods
The proportion of participants achieving complete control (CC) will be compared between the intervention and control groups during the acute period (0-24 hours), delayed period (24-120 hours), and overall period (0-120 hours) after chemotherapy. CC is defined as no vomiting, no use of rescue antiemetic medication, and no significant nausea during the corresponding observation period. No significant nausea is defined as a nausea VAS score consistently below 25 mm throughout the corresponding observation period.
Measured: 0-120 hours after initiation of chemotherapy
Proportion of Participants With No Impact of CINV on Daily Life
The impact of chemotherapy-induced nausea and vomiting (CINV) on daily life will be assessed using the Functional Living Index-Emesis (FLIE). The proportion of participants with no impact of CINV on daily life will be compared between the intervention and control groups. A total FLIE score of ≥108 is defined as no impact on daily life.
Measured: 120 hours after initiation of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuming Qiu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848984
- Sponsor's protocol ID
- 2026-0934
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chinese Herbal Acupoint Application Combined With Triple Antiemetic Therapy for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07848984
- Acronym / sponsor ID
- 2026-0934
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Antiemetics, Nausea, Vomiting, Acupressure, Medicine, Chinese Traditional
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Sep 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 whether Chinese herbal acupoint application, when added to standard three-drug anti-nausea treatment, can prevent nausea and vomiting caused by chemotherapy in people with breast cancer. The study will also evaluate the safety of the Chinese herbal acupoint application.
The main questions it aims to answer are:
- Does Chinese herbal acupoint application help participants have less nausea during the first 5 days after chemotherapy?
- Does it reduce vomiting and the need for additional anti-nausea medicine?
- Does it affect the impact of chemotherapy-related nausea and vomiting on daily life?
- What medical problems or side effects occur with the Chinese herbal acupoint application?
Researchers will compare Chinese herbal acupoint application with a sham application. Both groups will receive standard three-drug anti-nausea treatment. The sham application looks and feels similar to the herbal application but does not contain the active herbal ingredients.
Participants will:
- Receive one cycle of planned chemotherapy and standard three-drug anti-nausea treatment.
- Receive either the Chinese herbal acupoint application or sham application before chemotherapy. The application will be placed on selected acupuncture points for 4 to 6 hours.
- Record nausea, vomiting, and use of additional anti-nausea medicine during the first 5 days after chemotherapy.
- Complete a questionnaire about how nausea and vomiting affect daily life.
- Have safety follow-up for about 2 weeks after chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Herbal Acupoint Application | Experimental | Other: Chinese Herbal Acupoint Application, Drug: Standard Triple Antiemetic TherapyParticipants will receive Chinese herbal acupoint application before chemotherapy on Day 1. The herbal paste contains Chinese herbal medicines and will be applied to the Conception Vessel 12 (CV12), Conception Vessel 8 (CV8), and bilateral Pericardium 6 (PC6) acupoints. The patch will remain in place for 4 to 6 hours and will then be removed. Participants will also receive standard three-drug antiemetic treatment as planned for their chemotherapy. |
| Sham Acupoint Application | Sham comparator | Other: Sham Acupoint Application, Drug: Standard Triple Antiemetic TherapyParticipants will receive a sham acupoint application before chemotherapy on Day 1. The sham patch will have the same appearance, size, color, smell, and base material as the herbal patch, but will not contain any of the active Chinese herbal ingredients. The sham patch will remain in place for 4 to 6 hours and will then be removed. Participants will also receive standard three-drug antiemetic treatment as planned for their chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years, regardless of sex；
- Pathologically confirmed operable breast cancer with no prior systemic chemotherapy；
- Planned to receive one of the following highly emetogenic chemotherapy (HEC) regimens. HEC refers to chemotherapy regimens associated with an expected incidence of vomiting of >90% in the absence of prophylactic antiemetic treatment, including anthracycline/cyclophosphamide-based regimens (AC, TC, or EC) and carboplatin-containing regimens (e.g., TCbH, TCbHP)；
- Planned to receive triple antiemetic prophylaxis consisting of an NK-1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone. NK-1 receptor antagonists may include fosrolapitant, aprepitant, fosaprepitant, or other approved agents; 5-HT3 receptor antagonists may include palonosetron, ondansetron, or other approved agents；
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
Key exclusion criteria (12 listed)
- Skin damage, ulceration, scarring, or severe infection at the intended application sites;
- Known history of severe allergy to any adhesive tape, patch materials, or herbal/other ingredients used in the study;
- Significant nausea (VAS ≥25 mm) within 24 hours before chemotherapy that, in the investigator's judgment, is not related to chemotherapy;
- Refractory vomiting due to non-chemotherapy-related causes, such as complete intestinal obstruction or severe vomiting caused by increased intracranial pressure secondary to brain metastases;
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Chinese Herbal Acupoint ApplicationOn Day 1, before chemotherapy, participants will receive Chinese herbal acupoint application in addition to standard triple antiemetic therapy. The herbal preparation consists of Ginger-processed Pinellia 90 g, Coptis Rhizome 30 g, Magnoliae Officinalis Cortex 120 g, Ginger-processed Caulis Bambusae in Taeniam 100 g, Evodia fruit 30 g, Dried Tangerine Peel 60 g, and clove flower bud 60 g. The herbs are mixed into powder. For each application, 50 g of herbal powder is mixed with 50 mL normal saline and 50 g medical petrolatum to form a paste. Approximately 1 cm-diameter herbal patches are prepared and applied to the Conception Vessel 12 (CV12), Conception Vessel 8 (CV8), and bilateral Pericardium 6 (PC6) acupoints. The patches are removed after 4-6 hours. | Other | Chinese Herbal Acupoint Application |
| Sham Acupoint ApplicationOn Day 1, before chemotherapy, participants will receive sham acupoint application in addition to standard triple antiemetic therapy. The sham patches will be identical to the herbal patches in appearance, size, matrix color, odor, and backing material. The sham matrix will contain petrolatum, medical adhesive, and starch, without any active herbal ingredients. The sham patches are not intended to exert pharmacological effects through the skin. The patches will be applied to the Conception Vessel 12 (CV12), Conception Vessel 8 (CV8), and bilateral Pericardium 6 (PC6) acupoints and removed after 4-6 hours. | Other | Sham Acupoint Application |
| Standard Triple Antiemetic TherapyAll participants will receive a standard triple antiemetic regimen consisting of an NK-1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone according to the study protocol and clinical practice. NK-1 receptor antagonists may include fosrolapitant, aprepitant, or fosaprepitant. 5-HT3 receptor antagonists may include palonosetron or ondansetron. The specific antiemetic agent and dosing regimen will be selected according to the chemotherapy regimen and the study protocol. | Drug | Chinese Herbal Acupoint Application, Sham Acupoint Application |
Primary outcome
Proportion of Participants With No Significant Nausea (NSN) During 0-120 Hours After Chemotherapy
Time frame: 0-120 hours after initiation of chemotherapy
No Significant Nausea (NSN) is defined as a nausea score consistently below 25 mm on a 100-mm visual analogue scale (VAS) throughout the 0-120-hour observation period after chemotherapy. The VAS ranges from 0 mm (no nausea) to 100 mm (worst imaginable nausea). The outcome measure is the proportion of participants who meet the criteria for NSN during the overall 0-120-hour observation period.
5 secondary outcomes
Nausea Severity by VAS During Acute, Delayed, and Overall Periods
Time frame: 0-120 hours after initiation of chemotherapy
Proportion of Participants With No Significant Nausea During Acute and Delayed Periods
Time frame: 0-120 hours after initiation of chemotherapy
Complete Response (CR) Rate During Acute, Delayed, and Overall Periods
Time frame: 0-120 hours after initiation of chemotherapy
Complete Control (CC) Rate During Acute, Delayed, and Overall Periods
Time frame: 0-120 hours after initiation of chemotherapy
Proportion of Participants With No Impact of CINV on Daily Life
Time frame: 120 hours after initiation of chemotherapy
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 30 Sep 2026.
- 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.
Fuming Qiu principal investigator
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 Chinese Herbal Acupoint Application and Standard Triple Antiemetic Therapy in people with Breast Neoplasms, 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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 30 Sep 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. Some participants in this study may receive a placebo. 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 Fuming Qiu (86+13858005908, qiufuming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With No Significant Nausea (NSN) During 0-120 Hours After Chemotherapy (time frame: 0-120 hours after initiation of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.