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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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;
Show all 22Show fewer
- 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
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao, Dr, 869716230893, jiudazhao@126.com
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Jiuda Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06200168
- Acronym / sponsor ID
- AHQU-2023002
- Keywords
- electroacupuncture, olanzapine-contained four-drug antiemetic, nausea and Vomiting, breast cancer, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Jiuda ZhaoUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True acupuncture + standard quadruple antiemetic therapy | Experimental | Device: Electroacupuncture, Drug: Standard antiemetic treatmentParticipants 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. |
| Sham acupuncture + standard quadruple antiemetic therapy | Placebo comparator | Device: Sham electroacupuncture, Drug: Standard antiemetic treatmentThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureThe 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. | Device | True acupuncture + standard quadruple antiemetic therapy |
| Standard antiemetic treatmentOlanzapine 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. | Drug | True acupuncture + standard quadruple antiemetic therapy |
| Sham electroacupunctureThe 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. | Device | Sham acupuncture + standard quadruple antiemetic therapy |
| Standard antiemetic treatmentOlanzapine 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. | Drug | Sham acupuncture + standard quadruple antiemetic therapy |
Primary outcome
Proportion of patients with no nausea during the overall stage
Time frame: 120 hours
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.
13 secondary outcomes
Proportion of patients with no nausea during the early stage
Time frame: 24 hours
Proportion of patients with no nausea during the delayed stage
Time frame: 96 hours
The relationship between single nucleotide polymorphism 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).
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)
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)
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)
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)
Time frame: 120 hours
Quality of life in the overall stage
Time frame: 120 hours
Insomnia
Time frame: 120 hours
Fatigue
Time frame: 120 hours
Constipation
Time frame: 120 hours
The side effects of electroacupuncture treatment
Time frame: 120 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with no nausea during the overall stage (time frame: 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.