A Phase 2 interventional study of Chinese Herbal Acupoint Application and Sham Acupoint Application in Breast Neoplasms, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment
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:
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:
Exclusion Criteria:
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.
Other: Chinese Herbal Acupoint Application · Drug: Standard Triple Antiemetic Therapy
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.
Other: Sham Acupoint Application · Drug: Standard Triple Antiemetic Therapy
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.
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.
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.
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.
Time frame: 0-120 hours after initiation of chemotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 120 hours after initiation of chemotherapy
Plan to share: No
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Second Affiliated Hospital, Zhejiang University, School of Medicine