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This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy. Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast cancer survivors with the psychoneurological symptom cluster who are currently being treated with endocrine therapy. Participants will receive 16 treatments over 8 weeks. The EA group will receive true acupuncture with continuous wave stimulation (2Hz, intensity as tolerated) administered for 30 minutes per session. The SA group will receive sham acupuncture using blunt (non-penetrating) needles that contact the skin without penetration, along with a 30-second transient device activation instead of the 30-minute continuous stimulation. Treatment outcomes for pain, fatigue, insomnia, anxiety, depression and subjective cognitive function will be assessed. The primary outcome is response rate of the psychoneurological symptom cluster after 8 weeks of treatment. Secondary outcomes include changes from baseline in the scores of each of the six psychoneurological symptoms.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Senior Department of Oncology,Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of CACMS
Beijing, Beijing Municipality, China
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, China
Qingdao Traditional Chinese Medicine Hospital, Qingdao Hiser Hospital Affiliated of Qingdao University
Qingdao, Shandong, China
Tianjin Medical University Cancer Institute & Hospital (TMUCIH)
Tianjin, Tianjin Municipality, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Start Date
April 1, 2026
Primary Completion Date
June 1, 2028
Completion Date
July 1, 2028
Last Updated
March 19, 2026
228
ESTIMATED participants
electroacupuncture
DEVICE
sham electroacupuncture
DEVICE
Lead Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
NCT06346132
NCT07351968
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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