A Phase 3 interventional study of Electroacupuncture and Standard antiemetic treatment in Electroacupuncture, Olanzapine-contained Four-drug Antiemetic and Nausea and Vomiting, sponsored by Jiuda Zhao. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Jiuda Zhao · Phase 3, Interventional, and Treatment
This randomized controlled phase III trial aims to evaluate the use of electroacupuncture in combination with olanzapine-containing standard quadruple antiemetic drugs for the treatment of nausea and vomiting induced by highly emetogenic chemotherapy (HEC) in patients with breast cancer. Furthermore, it will analyze the relationship between single nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea and vomiting.
This study is a parallel-group, blinded (participants, evaluators, and statisticians), randomized controlled trial exploring the effectiveness of electroacupuncture combined with standard quadruple antiemetic drugs for breast cancer patients undergoing HEC. Both groups will receive Olanzapine, Neurokinin-1 receptor antagonists (NK-1RAs), serotonin receptor antagonists [5HT3RA], and dexamethasone at the start of HEC on Day 1. Electroacupuncture or sham acupuncture will be randomly administered to each group. Participants will document all instances of nausea and vomiting and note the use of rescue antiemetic medications. Blood samples will be collected and analyzed to investigate whether genetic polymorphisms can predict electroacupuncture outcomes in breast cancer patients undergoing HEC. Primary and secondary outcomes as well as adverse events will be assessed.
Exclusion Criteria:
Participants will receive electroacupuncture once daily from day 1 to day 4. The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz. They will receive olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.
Device: Electroacupuncture · Drug: Standard antiemetic treatment
The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group.Care was taken to avoid "de qi" sensation. They will receive olanzapine-contained four-drug antiemetic therapy. All the antiemetic drugs used are the same as those in the true acupuncture group.
Device: Sham electroacupuncture · Drug: Standard antiemetic treatment
The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz.
Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.
The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group.Care was taken to avoid "de qi" sensation.
Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg IV or ondansetron 8 mg IV or tropisetron 5 mg IV (the previously mentioned medication, which includes fosaprepitant or aprepitant combined with palonosetron or ondansetron or tropisetron, can also be taken orally in a fixed combination of netupitant (300 mg) and palonosetron (0.50 mg))+ dexamethasone 10 mg IV 30 minutes prior to chemotherapy on Day 1, dexamethasone 8 mg IV on days 2, 3, 4 post chemotherapy. Dexamethasone doses may be individualized based on the doctor's judgment.All the antiemetic drugs used are the same as those in the true acupuncture group.
Proportion of patients with no nausea during the overall stage
The proportion of patients achieving no nausea is defined as patients who have a response of 0 on the Visual Analog Scale for nausea during the overall stage (0 to 120 hours) after the initiation of chemotherapy.
Time frame: 120 hours
Proportion of patients with no nausea during the early stage
The proportion of patients achieving no nausea is defined as patients who have a response of 0 on the Visual Analog Scale for nausea during the early stage (0 to 24 hours) after the initiation of chemotherapy
Time frame: 24 hours
Proportion of patients with no nausea during the delayed stage
The proportion of patients achieving no nausea is defined as patients who have a response of 0 on the Visual Analog Scale for nausea during the later stage (25 to 120 hours) after the initiation of chemotherapy
Time frame: 96 hours
The relationship between single nucleotide polymorphism genotypes and the proportion of patients with no nausea
The single nucleotide polymorphism (SNP) genotypes will be analyzed by detecting different bases (A, T, C, and G) in peripheral blood DNA. The proportion of patients with different SNP genotypes will be analyzed. The proportion of patients achieving no nausea is defined as patients who score 0 on the nausea Visual Analog Scale during the entire period (0 to 120 hours) following the initiation of chemotherapy. We will analyze the relationship between the proportion of patients with different SNP genotypes and the proportion of patients with no nausea
Time frame: 120 hours
The proportion of patients achieving total control in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours).
The proportion of patients achieving overall stage, early stage and delayed stage total control is defined as patients who have no vomiting/retching or rescue medications, and no nausea, specifically indicated by a nausea Visual Analog Scale score of 0 during 0 to 120 hours, 0 to 24 hours, and 25 to 120 hours after the initiation of chemotherapy, respectively
Time frame: 120 hours
The proportion of patients achieving complete protection in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)
The proportion of patients achieving overall stage, early stage and delayed stage complete protection is defined as patients who have no vomiting/retching or rescue medications, and no significant nausea, specifically indicated by a nausea Visual Analog Scale score of less than 25 mm during 0 to 120 hours, 0 to 24 hours, and 25 to 120 hours after the initiation of chemotherapy, respectively
Time frame: 120 hours
The proportion of no significant nausea in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)
The proportion of patients achieving overall stage, early stage and delayed stage no significant nausea is defined as patients who have no significant nausea, specifically indicated by a nausea Visual Analog Scale score of less than 25 mm during 0 to 120 hours, 0 to 24 hours, and 25 to 120 hours after the initiation of chemotherapy, respectively
Time frame: 120 hours
The proportion of no nausea (Visual Analog Scale score < 5) in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)
The proportion of patients achieving overall stage, early stage and delayed stage no nausea (Visual Analog Scale score \< 5) is defined as patients who have no nausea (Visual Analog Scale score \< 5), specifically indicated by a nausea Visual Analog Scale score \< 5 mm during 0 to 120 hours, 0 to 24 hours, and 25 to 120 hours after the initiation of chemotherapy, respectively
Time frame: 120 hours
The proportion of patients achieving complete response in the overall stage, the early stage (0 to 24 hours), and the delayed stage (25 to 120 hours)
The proportion of patients achieving overall stage complete response is defined as patients who have no vomiting/retching or rescue medications during 0 to 120 hours, 0 to 24 hours, and 25 to 120 hours after the initiation of chemotherapy, respectively
Time frame: 120 hours
Quality of life in the overall stage
EuroQol Five Dimensions Questionnaire (EQ-5D) is a standardized instrument used for assessing an individual's health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels that describe the person's level of functioning or well-being in that specific area. Additionally, EQ-5D includes a Visual Analog Scale where individuals rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health)
Time frame: 120 hours
Insomnia
The proportion of patients with insomnia evaluated by Common Terminology Criteria for adverse events Version 5.0 during 0 to120 hours after the initiation of chemotherapy
Time frame: 120 hours
Fatigue
The proportion of patients with fatigue evaluated by Common Terminology Criteria for adverse events Version 5.0 during 0 to120 hours after the initiation of chemotherapy
Time frame: 120 hours
Constipation
The proportion of patients with constipation evaluated by Common Terminology Criteria for adverse events Version 4.0 during 0 to120 hours after the initiation of chemotherapy
Time frame: 120 hours
The side effects of electroacupuncture treatment
The proportion of side effects related to electroacupuncture treatment in patients evaluated by Common Terminology Criteria for adverse events Version 5.0 during 0 to120 hours after the initiation of chemotherapy
Time frame: 120 hours
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Jiuda Zhao