Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors

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.

Sex

Female

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria：

1. Female, aged 18-75 years;
2. Histologically confirmed Stage 0, I, II, or III breast cancer (according to the AJCC 8th edition)；
3. Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least 1 month prior to study initiation , and are currently receiving endocrine therapy；
4. 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 Criteria:

1. History of psychiatric disorders (e.g., bipolar disorder, schizophrenia, substance addiction)
2. Presence of diseases that may impair cognitive function or interfere with study assessments (e.g., Alzheimer's disease, Parkinson's disease, brain tumors).
3. Fatigue attributable to a treatable condition (e.g., hypothyroidism).
4. Severe debilitation or significant organic disease (e.g., heart failure, severe hepatic/renal insufficiency, severe anemia, uncontrolled infection).
5. Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks.
6. Chronic use of corticosteroids.
7. Prior acupuncture treatment within 3 months, or participation in an acupuncture or drug clinical trial within 6 months.
8. History of hemorrhagic disease, severe coagulation dysfunction, or current use of anticoagulants (e.g., warfarin).
9. Implanted cardiac pacemaker.
10. Pregnancy or breastfeeding.
11. Concurrent participation in another clinical study.

• BACKGROUNDLu Y, Zhao Q, Zou J, Yan S, Tamaresis JS, Nelson L, Tu XM, Chen J, Tian L. A Composite Endpoint for Treatment Benefit According to Patient Preference. Stat Biopharm Res. 2022;14(4):408-422. doi: 10.1080/19466315.2022.2085783. Epub 2022 Jul 19. PMID 37981982
• BACKGROUNDKwon KK, Lacey J, Kerin-Ayres K, Heller G, Grant S. Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial. Support Care Cancer. 2024 May 7;32(6):332. doi: 10.1007/s00520-024-08529-9. PMID 38713422
• BACKGROUNDLi H, Doorenbos AZ, Chen Z, Choi H, Ma W, Danciu O, Patil CL, Gao S, Lif N, Schlaeger JM. Feasibility and Acceptability of Integrating Acupuncture for Management of Multiple Symptoms in Medically Underserved Breast Cancer Survivors. Cancers (Basel). 2025 Jan 18;17(2):304. doi: 10.3390/cancers17020304. PMID 39858086
• BACKGROUNDLiao HY, Satyanarayanan SK, Lin YW, Su KP. Clinical efficacy and immune effects of acupuncture in patients with comorbid chronic pain and major depression disorder: A double-blinded, randomized controlled crossover study. Brain Behav Immun. 2023 May;110:339-347. doi: 10.1016/j.bbi.2023.03.016. Epub 2023 Mar 21. PMID 36948325
• BACKGROUNDCui J, Song W, Jin Y, Xu H, Fan K, Lin D, Hao Z, Lin J. Research Progress on the Mechanism of the Acupuncture Regulating Neuro-Endocrine-Immune Network System. Vet Sci. 2021 Jul 30;8(8):149. doi: 10.3390/vetsci8080149. PMID 34437474
• BACKGROUNDSun B, Cao X, Xin M, Guan R. Treatment of Depression with Acupuncture Based on Pathophysiological Mechanism. Int J Gen Med. 2024 Jan 31;17:347-357. doi: 10.2147/IJGM.S448031. eCollection 2024. PMID 38314195
• BACKGROUNDGeorge MA, Lustberg MB, Orchard TS. Psychoneurological symptom cluster in breast cancer: the role of inflammation and diet. Breast Cancer Res Treat. 2020 Nov;184(1):1-9. doi: 10.1007/s10549-020-05808-x. Epub 2020 Aug 15.