Combining electroacupuncture with antiemetic therapy for nausea in breast cancer patients

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

This study is testing if combining electroacupuncture with standard anti-nausea medication can help breast cancer patients feel less sick during chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Lanzhou University Second Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Lanzhou, Gansu)
• Trial ID: NCT06314906 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining electroacupuncture with a four-drug antiemetic regimen, including olanzapine, to alleviate chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients. It is a randomized controlled trial where participants will receive either electroacupuncture or sham acupuncture alongside standard antiemetic therapy during highly emetogenic chemotherapy. The study aims to evaluate the synergistic effects of these treatments and monitor their impact on nausea and vomiting, as well as any adverse events. Participants will document their experiences to provide comprehensive data on treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with early-stage breast cancer undergoing highly emetogenic chemotherapy.

Not a fit: Patients with ongoing severe nausea or vomiting, significant medical conditions, or those who fear electroacupuncture may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce nausea and vomiting in breast cancer patients undergoing chemotherapy, improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with acupuncture in managing chemotherapy-induced nausea, suggesting potential success for this combined approach.

Eligibility criteria

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.

Where this trial is running

Lanzhou, Gansu

• Second Hospital of Lanzhou University — Lanzhou, Gansu, China (RECRUITING)

Study contacts

• Study coordinator: Feixue Song, Dr

Conditions: Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting, electroacupuncture, olanzapine-contained four-drug antiemetic, nausea and Vomiting, breast cancer, chemotherapy