Chinese Herbal Acupoint Application Combined With Triple Antiemetic Therapy for Prevention of Chemotherapy-Induced Nausea and Vomiting in Breast Cancer

Official record

Identifier

NCT07848984

Recruiting locations

country

China

Interventions studied

Chinese Herbal Acupoint ApplicationSham Acupoint ApplicationStandard Triple Antiemetic Therapy

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Target enrolment

190 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Not yet recruiting

First posted

Sep 30, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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。

Exclusion Criteria:

* 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;
* 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.

Indexed under

Breast Cancer