Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

Feixue Song

Status and phase: Enrolling; Phase 3

Conditions: Nausea and Vomiting; Olanzapine-contained Four-drug Antiemetic; Electroacupuncture

Treatments: Drug: Antiemetic Therapy; Device: Sham electroacupuncture; Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06314906

SHLU-2024001

Details and patient eligibility

About

This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.

Full description

This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture.

Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications.

The study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Enrollment: 370 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients aged 18 to 75 years, inclusive, from any nationality.
2. Patients diagnosed with early-stage breast cancer.
3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2.
4. All patients must undergo highly emetogenic chemotherapy (HEC).
5. Adequate organ function.
6. Adequate contraception required for premenopausal women.

Exclusion criteria

1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.
3. Significant medical or psychological conditions.
4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
6. Any known allergies to the study drug, antiemetics, or dexamethasone.
7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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370 participants in 2 patient groups, including a placebo group

True Acupuncture Combined with Antiemetic Therapy

Experimental group

Description:

Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz.

Treatment:

Drug: Antiemetic Therapy

Drug: Antiemetic Therapy

Device: Electroacupuncture

Antiemetic therapy

Placebo Comparator group

Description:

Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.

Treatment:

Drug: Antiemetic Therapy

Drug: Antiemetic Therapy

Device: Sham electroacupuncture