ElectroacupuncturePhase 3NCT06200168

Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer

A Phase 3 study testing Electroacupuncture and Standard antiemetic treatment in people with Electroacupuncture and Olanzapine-contained Four-drug Antiemetic, run by Jiuda Zhao at 1 site in China.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting
What is being tested?: Electroacupuncture and Standard antiemetic treatment
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 370 participants
Where: 1 siteChina
Study dates: 16 Jan 2024to 31 Dec 2026
Phase: Phase 3

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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 18 years or older and aged 75 years or younger, of any nationality;
Eastern Cooperative Oncology Group performance status of 0-2;
Patients with breast cancer, with no restrictions on molecular typing; early-stage patients must not have undergone prior chemotherapy, while advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin;
Predicted life expectancy of ≥3 months;
Adequate bone marrow, kidney, and liver function;
Adequate contraception if premenopausal women;
Written informed consent by the patient before enrolment.

Who cannot join

Patients already submitted to chemotherapy;
Is scheduled to receive any non-HEC on Day 1;
Is scheduled to receive any chemotherapy on days 2-4 after HEC;
Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;
Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
Have ongoing emesis or CTCAE grade 2 or greater nausea;

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Significant medical or mental conditions;
Any allergies to study drug, antiemetics or dexamethasone;
Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);
Patients who are pregnant or breast-feeding;
Inflammatory skin reaction;
Has lymphedema in acupuncture stimulation area;
Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
Received acupuncture treatments for any conditions less than 4 weeks before HEC;
Currently using drugs with antiemetic activity (e.g., 5-HT3 receptor antagonists, corticosteroids (except when used at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nocturnal sedation));
Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;
Has a convulsive disorder requiring anticonvulsant treatment;
Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);
Concurrent treatment with quinolone antibiotics;
Has a history of chronic alcoholism (determined by the investigator);
Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;
Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).

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, 1 recruiting

Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao, Dr, 869716230893, jiudazhao@126.com
Recruiting

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About this study

Official title: A Study on Electroacupuncture Combined With Olanzapine-contained Four-drug Antiemetic Therapy for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer (ECO Study)

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.

Read the detailed description

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.

Conditions: Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting
Being tested: Electroacupuncture, Standard antiemetic treatment, Sham electroacupuncture
Keywords: electroacupuncture, olanzapine-contained four-drug antiemetic, nausea and Vomiting, breast cancer, chemotherapy
Medical subject headings: Nausea, Vomiting, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElectroacupunctureDevice
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.
Standard antiemetic treatmentDrug
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.
Sham electroacupunctureDevice
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.
Standard antiemetic treatmentDrug
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.

Study groups in NCT06200168
Study group	Role	What they receive
True acupuncture + standard quadruple antiemetic therapy	Experimental	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. Receives: Device: Electroacupuncture; Drug: Standard antiemetic treatment
Sham acupuncture + standard quadruple antiemetic therapy	Placebo comparator	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. Receives: Device: Sham electroacupuncture; Drug: Standard antiemetic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 120 hours

Secondary outcomes (13)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 202431 Dec 2026

First posted10 Jan 2024
Study start16 Jan 2024
Primary completion31 Oct 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ElectroacupunctureStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 370 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06200168
Sponsor's protocol ID: AHQU-2023002
Status last verified: Mar 2025
First submitted: 20 Dec 2023
Last updated: 2 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

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Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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