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

NCT06314906 | Recruiting Phase 3 DMC

• 1 other identifier: SHLU-2024001
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

electroacupuncture; olanzapine-contained four-drug antiemetic; nausea and Vomiting; breast cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

True Acupuncture Combined with Antiemetic Therapy

EXPERIMENTAL

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.

Device: Electroacupuncture; Drug: Antiemetic Therapy

Antiemetic therapy

PLACEBO COMPARATOR

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.

Device: Sham electroacupuncture; Drug: Antiemetic Therapy

Interventions

Electroacupuncture DEVICE

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

True Acupuncture Combined with Antiemetic Therapy

Antiemetic Therapy DRUG

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.

True Acupuncture Combined with Antiemetic Therapy

Sham electroacupuncture DEVICE

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

Antiemetic therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Feixue Song: lead

Study Sites (1)

Second Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting; Breast Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Feixue Song, Dr

CONTACT

13639336037; 13639336037@139.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)