Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07481903, who can take part
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- How often do I need to come in, and for how long each time?
- Are travel costs paid?
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- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Trial code
- NCT07481903
- Record updated
- 19 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Female, aged 18-75 years; Histologically confirmed Stage 0, I, II, or III breast cancer (according to the AJCC 8th edition)；; Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least 1 month prior to study initiation , and are currently receiving endocrine therapy；; Meet at least 2 of the following 6 criteria:; (1)Visual Analogue Scale (VAS) score for pain ≥ 4 (2)Pittsburgh Sleep Quality Index (PSQI) score ≥ 8 (3)Brief Fatigue Inventory-Chinese version (BFI-C) score ≥ 4 (4)Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score ≥ 8 (5)Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score ≥ 8 (6)Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments (FACT-Cog-PCI) score < 60 ; 5.Has signed the informed consent form and voluntarily participates in this study.
Exclusion: Chronic use of corticosteroids; Prior acupuncture treatment within 3 months, or participation in an acupuncture or drug clinical trial within 6 months; Concurrent participation in another clinical study; History of psychiatric disorders (e.g., bipolar disorder, schizophrenia, substance addiction); Presence of diseases that may impair cognitive function or interfere with study assessments (e.g., Alzheimer's disease, Parkinson's disease, brain tumors); Fatigue attributable to a treatable condition (e.g., hypothyroidism); Severe debilitation or significant organic disease (e.g., heart failure, severe hepatic/renal insufficiency, severe anemia, uncontrolled infection); History of hemorrhagic disease, severe coagulation dysfunction, or current use of anticoagulants (e.g., warfarin); Implanted cardiac pacemaker; Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks; Pregnancy or breastfeeding.