Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
ID06952920

Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer

Led by Jiuda Zhao · Updated on 2025-12-15

388

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how electroacupuncture may help manage gastrointestinal symptoms caused by chemotherapy in patients with breast cancer. This study combines clinical treatment evaluation with advanced multi-omics and genomic analyses to understand how electroacupuncture affects symptoms like nausea, vomiting, poor appetite, and dry mouth. The goal is to provide strong medical evidence and insights to improve electroacupuncture treatment strategies for these chemotherapy-related symptoms. Participants will receive either real electroacupuncture combined with a standard quadruple antiemetic therapy or sham electroacupuncture with the same antiemetic drugs. The antiemetic regimen includes olanzapine, dexamethasone, 5-HT3 receptor antagonists, and NK-1 receptor antagonists. Electroacupuncture involves stimulation at four specific points for 30 minutes per session, starting 1-2 hours before chemotherapy on day 1 and continuing daily for the next three days. The control group receives superficial needle insertion and inactive electrical stimulation on the same schedule. During the first five days after chemotherapy, researchers will monitor symptoms, collect weight and quality of life questionnaires, record medication use and adverse events, and perform laboratory tests. Blood samples will be stored every two chemotherapy cycles. The main outcome measured is the incidence of gastrointestinal symptoms within 120 hours post-chemotherapy. Additional assessments include symptom improvement, nausea and vomiting rates, complete response and protection rates, and quality of life scores. Safety and side effects will also be carefully tracked throughout the study.

CONDITIONS

Brief Title

Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed stage I-III breast cancer
  • ECOG Performance Status score of 0-1
  • Age between 18 and 75 years
  • Scheduled to receive highly emetogenic chemotherapy regimens during first cycle of neoadjuvant or adjuvant chemotherapy
  • No acupuncture treatment within one month before enrollment
  • Voluntary participation with written informed consent
  • Expected survival of at least 3 months
  • Premenopausal women agree to use contraception during study
  • Adequate bone marrow, liver, and kidney function by lab criteria
Not Eligible

You will not qualify if you...

  • Advanced-stage cancer
  • Concurrent chemoradiotherapy
  • Severe vital organ impairment intolerant to standard chemotherapy
  • Contraindications to acupuncture such as active skin infections
  • Digestive diseases with nausea or vomiting interfering with assessment
  • History of dry mouth (xerostomia)
  • Known allergies to study drugs
  • Pregnant or breastfeeding
  • Current use of antiemetic medications like 5-HT3 antagonists, corticosteroids (except physiological doses), dopamine antagonists, tranquilizers, antihistamines, benzodiazepines (except for nighttime sedation)
  • Seizure disorders needing anticonvulsant therapy
  • Use of thiazides as chronic antipsychotic medication
  • Known arrhythmias, uncontrolled heart failure, or recent heart attack

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days per chemotherapy cycle

Participants receive electroacupuncture or sham electroacupuncture combined with a standard quadruple antiemetic therapy during their first cycle of chemotherapy to manage chemotherapy-induced gastrointestinal symptoms.

Daily visits from Day 1 to Day 5

Follow-up

Duration - Up to 5 days after chemotherapy

Participants are monitored for chemotherapy-induced gastrointestinal symptoms, quality of life, and adverse events up to 120 hours after chemotherapy.

Visits included during the treatment period

Trial Site Locations

Total: 1 location

1

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial.

Xinlong Tao, Zhen Liu, Miaozhou Wang...

https://pubmed.ncbi.nlm.nih.gov/41767166