Combining electroacupuncture with antiemetic therapy for nausea in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Second Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting

Study contacts

• Study coordinator: Feixue Song, Dr
• Email: 13639336037@139.com
• Phone: 13639336037

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Zusanli (ST36) electroacupuncture plus immunotherapy in NSCLC before surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.