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.
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；
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;
Parallel
Chinese Herbal Acupoint Application
Other interventionOn 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 Application
Other interventionOn 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 Therapy
DrugAll 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.
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.
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.
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.
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.
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.
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