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Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors
Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2026-04
Completion Date
2028-07
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
electroacupuncture
A semi-standardized protocol is used for participants in the EA group, which includes (1) standardized acupoints (Midline: Baihui \[GV20\], Shenting \[GV24\], Qihai \[CV6\], Guanyuan \[CV4\]; Bilateral: Fengchi \[GB20\], Taiyang \[EX-HN5\], Zusanli \[ST36\], Hegu \[LI4\], Taichong \[LR3\]); and (2) additional acupoints (Sishencong \[EX-HN1\] and bilateral Benshen \[GB13\] for anxiety/depression/subjective cognitive decline; 1-2 Ashi points for pain; no additional points for insomnia/fatigue). Meanwhile, electrical stimulation is conducted on three pairs of acupoints with electrode cord connection as follows: Baihui \[GV20\] and Shenting \[GV24\], left Fengchi \[GB20\] and left Taiyang \[EX-HN5\], right Fengchi \[GB20\] and right Taiyang \[EX-HN5\]. Electrical stimulation is delivered in continuous wave mode at 2 Hz with current intensity adjusted according to participant's tolerance. Electrical stimulation last 30 min. The needles on body acupoints are also retain for 30 min.
sham electroacupuncture
In the SA group, noninsertive simulated acupuncture and sham electrical stimulation(30-second transient device activation instead of 30-minute continuous stimulation) are used, while maintaining the same treatment duration and course as the EA group. Blunt needles are placed on 12 acupoints (Bilateral: Fengchi \[GB20\], Taiyang \[EX-HN5\], Zusanli \[ST36\], Hegu \[LI4\], Taichong \[LR3\]; Midline: Qihai \[CV6\], Guanyuan \[CV4\]) without skin penetration. Electrical stimulation is conducted on two pairs of acupoints with electrode cord connection as follows: left Fengchi \[GB20\] and left Taiyang \[EX-HN5\], right Fengchi \[GB20\] and right Taiyang \[EX-HN5\]. A 2 Hz continuous wave is delivered for 30 seconds, after which the EA device is immediately turned off. The blunt needles are maintained in position for 30 minutes to match the retention time in the EA group.
Locations (6)
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