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/41767166Actively Recruiting
Led by Jiuda Zhao · Updated on 2025-12-15
388
Participants Needed
1
Research Sites
N/A
Total Duration
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
Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Xinlong Tao, Zhen Liu, Miaozhou Wang...
https://pubmed.ncbi.nlm.nih.gov/41767166