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

Nausea and Vomiting Clinical Trial

Official title:

Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314906
• Other study ID #: SHLU-2024001
• Status: Recruiting
• Phase: Phase 3
• Start date: March 7, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: The Second Hospital of Lanzhou University
• Contact: Feixue Song, Dr
• Phone: 13639336037
• Email: 13639336037[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: March 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electroacupuncture
• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Device:
• Electroacupuncture
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

Drug:
• Antiemetic Therapy
Participants will receive oral olanzapine at a dose of 5 mg per day on days 1 through 4, along with NK1 receptor antagonist, 5HT3 receptor antagonist, and intravenous dexamethasone at a dose of 10 mg 30 minutes prior to chemotherapy on Day 1, followed by intravenous dexamethasone at a dose of 8 mg on days 2, 3, and 4 post-chemotherapy.

Device:
• Sham electroacupuncture
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group

Drug:
• Antiemetic Therapy
They will also receive the same antiemetic medications as the experimental group.

Locations

Country	Name	City	State
China	Second Hospital of Lanzhou University	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Feixue Song

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Free from Nausea Throughout Treatment	The proportion of patients experiencing no nausea is determined by those who register a score of 0 on the visual-analogue scale for nausea throughout the entirety of treatment, spanning from initiation of chemotherapy to 120 hours post-treatment.	120 hours