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

RECRUITING

NCT06200168

PHASE3

Sponsor: Jiuda Zhao

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. Furthermore, it will analyze the relationship between single nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea and vomiting.

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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2024-01-16

Completion Date

2026-12-31

Last Updated

2025-04-02

Healthy Volunteers

Yes

Conditions

Electroacupuncture Olanzapine-contained Four-drug Antiemetic Nausea and Vomiting

Interventions

DEVICE

Electroacupuncture

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.

DRUG

Standard antiemetic treatment

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

Sham electroacupuncture

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.

DRUG

Standard antiemetic treatment

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.

Inclusion Criteria: 1. Aged 18 years or older and aged 75 years or younger, of any nationality; 2. Eastern Cooperative Oncology Group performance status of 0-2; 3. 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; 4. Predicted life expectancy of ≥3 months; 5. Adequate bone marrow, kidney, and liver function; 6. Adequate contraception if premenopausal women; 7. Written informed consent by the patient before enrolment. Exclusion Criteria: 1. Patients already submitted to chemotherapy; 2. Is scheduled to receive any non-HEC on Day 1; 3. Is scheduled to receive any chemotherapy on days 2-4 after HEC; 4. 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; 5. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting; 6. Have ongoing emesis or CTCAE grade 2 or greater nausea; 7. Significant medical or mental conditions; 8. Any allergies to study drug, antiemetics or dexamethasone; 9. Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine); 10. Patients who are pregnant or breast-feeding; 11. Inflammatory skin reaction; 12. Has lymphedema in acupuncture stimulation area; 13. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles; 14. Received acupuncture treatments for any conditions less than 4 weeks before HEC; 15. 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)); 16. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis; 17. Has a convulsive disorder requiring anticonvulsant treatment; 18. Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment); 19. Concurrent treatment with quinolone antibiotics; 20. Has a history of chronic alcoholism (determined by the investigator); 21. Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months; 22. Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).

Locations (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, China

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