Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors (NCT07481903) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors
China228 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years β 75 Years
SexFEMALE
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Inclusion criteria
β. Female, aged 18-75 years;
β. Histologically confirmed Stage 0, I, II, or III breast cancer (according to the AJCC 8th edition)οΌ
β. Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least 1 month prior to study initiation , and are currently receiving endocrine therapyοΌ
β. Meet at least 2 of the following 6 criteria:
Exclusion criteria
β. History of psychiatric disorders (e.g., bipolar disorder, schizophrenia, substance addiction)
β. Presence of diseases that may impair cognitive function or interfere with study assessments (e.g., Alzheimer's disease, Parkinson's disease, brain tumors).
β. Fatigue attributable to a treatable condition (e.g., hypothyroidism).
β. Severe debilitation or significant organic disease (e.g., heart failure, severe hepatic/renal insufficiency, severe anemia, uncontrolled infection).
β
What they're measuring
1
Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)
Timeframe: Week 8
Trial details
NCT IDNCT07481903
SponsorFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine