Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline)NCT07481903

Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors

A study testing electroacupuncture in people with Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline) and Pain, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 6 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline), Pain, Insomnia
What is being tested?: electroacupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 6 sitesChina
Study dates: Apr 2026to Jul 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).
Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks.
Chronic use of corticosteroids.

Show all 11Show fewer

Prior acupuncture treatment within 3 months, or participation in an acupuncture or drug clinical trial within 6 months.
History of hemorrhagic disease, severe coagulation dysfunction, or current use of anticoagulants (e.g., warfarin).
Implanted cardiac pacemaker.
Pregnancy or breastfeeding.
Concurrent participation in another clinical study.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shiyan Yan contact

+86 22 27986078

yanshiyan0927@sina.com

Ruihan Guo contact

+86 135 2033 6216

grh1882025@163.com

City, postcode or hospital

6 sites in 1 country

China6 sites

Senior Department of Oncology，Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Hua Song, PhD, +86 10-66947798, dzliyujun@163.com
Shaohua Zhang, PhD
Xiyuan Hospital of CACMS
Beijing, Beijing Municipality, 100091
JuLing Jiang, +86 10 62835438, 1192296624@qq.com
ZhongNing Guo, PhD
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, 210029
Jing Lu, +86 25 68306522, lujing0728@163.com
Jing Lu, PhD
Qingdao Traditional Chinese Medicine Hospital, Qingdao Hiser Hospital Affiliated of Qingdao University
Qingdao, Shandong, 266000
YiBo He, +86 532 83777906, heyibozyy@126.com
Bo Liu, PhD
Tianjin Medical University Cancer Institute & Hospital (TMUCIH)
Tianjin, Tianjin Municipality, 300060
Bin Wang, PhD, +86 22 23340123-6417, wbin8888@163.com
Bin Wang, PhD
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300381
ZiYu Kuang, PhD, +86 22 27986525, kzy1303088356@163.com
FanMing Kong, PhD

Other trials in China

About this study

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.

Conditions: Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline), Pain, Insomnia, Anxiety, Fatigue, Depression
Being tested: electroacupuncture, sham electroacupuncture
Keywords: Psychoneurological Symptom Cluster, Breast Cancer, Acupuncture
Medical subject headings: Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Fatigue, Depression, Pain, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

electroacupunctureDevice
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 electroacupunctureDevice
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.

Study groups in NCT07481903
Study group	Role	What they receive
EA group	Experimental	Participants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks. Receives: Device: electroacupuncture
SA group	Sham comparator	Participants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks. Receives: Device: sham electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)
The response rate is defined as the proportion of participants classified as responders. Improvement in each of the six psychoneurological symptoms is assessed using the following validated instruments: pain is measured by the Visual Analogue Scale (VAS); sleep quality by the Pittsburgh Sleep Quality Index (PSQI); fatigue by the Chinese version of the Brief Fatigue Inventory (BFI-C); anxiety and depression by the Hospital Anxiety and Depression Scale (HADS); and subjective cognitive function by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). A participant is deemed a responder if the post treatment improvement from baseline meets or exceeds the minimum clinically important difference (MCID) for at least two of the six symptoms.
Measured: Week 8

Secondary outcomes (11)

Response rate of psychoneurological symptom cluster (after 4 weeks of treatment and 12-week follow-up)
The definition and calculation method of the response rate are consistent with those of the primary outcome measure.
Measured: Week 4, Week 12
Change from Baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Score
Quality of life is measured by the Chinese version of FACT-B, which consists of 36 items. The total scale score ranges from 0 to 144, with higher scores indicating better quality of life.
Measured: Baseline (Week 0), Week 4, Week 8, Week 12
Change from Baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Total and Subscale Scores
The FACT-Cog is a 37-item self-response measure to assess cognitive concerns of cancer patients, consisting of four subscales: Perceived Cognitive Impairments (20 items, range 0-80), Comments from Others (4 items, range 0-16), Perceived Cognitive Abilities (9 items, range 0-36), and Impact on Quality of Life (4 items, range 0-16). A total cognitive functioning score is calculated as the sum of the four subscales. Higher scores indicate fewer cognitive difficulties.
Measured: Baseline (Week 0), Week 4, Week 8, Week 12
Change from Baseline in the Visual Analogue Scale (VAS) Score for Cancer/Treatment-Related Pain
The VAS intensity rating consists of a 10-cm line with the endpoints "no pain" and "worst pain". Study participants are asked to make a mark on the line that represents their current pain intensity, and the VAS pain intensity level is scored by measuring the distance from the "no pain" end of the line in millimeters.
Measured: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI consists of 18 items. Its global score ranges from 0 to 21, with higher scores indicating poor sleep quality and high sleep disturbance.
Measured: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Brief Fatigue Inventory-Chinese Version (BFI-C) Score
The BFI-C consists of 9 items. Its total score ranges from 0 to 10, with higher scores indicating greater fatigue.
Measured: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) Score
The HADS-A consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe anxiety.
Measured: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) Score
The HADS-D consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe depression.
Measured: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Acupuncture Expectation Evaluation
We will assess their expectations of acupuncture by asking questions after the first treatment. Participants will be asked two questions: "Do you think acupuncture may be effective?" and "Do you think acupuncture may be helpful for improving psychoneurological symptoms?". Their responses (Yes, No, or I don't know) will be collected for statistical analysis to evaluate the participants' expectations of acupuncture.
Measured: Within 5 minutes after the first treatment
Blinding assessment
To evaluate the success of blinding among participants in this study, blinding assessment will be performed. Specifically, participants will be asked a specific question within 5 minutes after the first treatment and again within 5 minutes after the last treatment to ascertain their awareness of their group assignment.
Measured: Within 5 minutes after the first treatment， Within 5 minutes after the last treatment
Safety Assessment
The occurrence of acupuncture-related and general adverse events (including serious adverse events [SAEs]) is documented in detail throughout the study.
Measured: The entire study period (Week 0 [Baseline] to Week 12 [Follow-up])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2026Jul 2028

First posted19 Mar 2026
Study startApr 2026 (estimated)
Primary completionJun 2028 (estimated)
Study completionJul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 228 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07481903
Sponsor's protocol ID: 7252224
Status last verified: Feb 2026
First submitted: 8 Mar 2026
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lu 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.
PubMed 37981982
Kwon 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.
PubMed 38713422
Li 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.
PubMed 39858086
Liao 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.
PubMed 36948325
Cui 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.
PubMed 34437474
Sun 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.
PubMed 38314195
George 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.
PubMed 32803635
Li H, Lockwood MB, Schlaeger JM, Liu T, Danciu OC, Doorenbos AZ. Tryptophan and Kynurenine Pathway Metabolites and Psychoneurological Symptoms Among Breast Cancer Survivors. Pain Manag Nurs. 2023 Feb;24(1):52-59. doi: 10.1016/j.pmn.2022.09.002. Epub 2022 Oct 10.
PubMed 36229337
Grayson SC, Cummings MH, Wesmiller S, Bender C. The Cancer Genomic Integration Model for Symptom Science (CGIMSS): A Biopsychosocial Framework. Biol Res Nurs. 2023 Apr;25(2):210-219. doi: 10.1177/10998004221132250. Epub 2022 Oct 7.
PubMed 36206160
Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.
PubMed 32305573
Tong QY, Liu R, Gao Y, Zhang K, Ma W, Shen WD. Effect of Electroacupuncture Based on ERAS for Preoperative Anxiety in Breast Cancer Surgery: A Single-Center, Randomized, Controlled Trial. Clin Breast Cancer. 2022 Oct;22(7):724-736. doi: 10.1016/j.clbc.2022.04.010. Epub 2022 Apr 30.
PubMed 35739000
Zhang J, Qin Z, So TH, Chang TY, Yang S, Chen H, Yeung WF, Chung KF, Chan PY, Huang Y, Xu S, Chiang CY, Lao L, Zhang ZJ. Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial. Breast Cancer Res. 2023 Apr 26;25(1):49. doi: 10.1186/s13058-023-01645-0.
PubMed 37101228
Hershman DL, Unger JM, Greenlee H, Capodice J, Lew DL, Darke A, Minasian LM, Fisch MJ, Henry NL, Crew KD. Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor-Related Joint Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241720. doi: 10.1001/jamanetworkopen.2022.41720.
PubMed 36367721
Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012 Dec 20;30(36):4470-6. doi: 10.1200/JCO.2012.41.6222. Epub 2012 Oct 29.
PubMed 23109700
Sheikh-Wu SF, Kauffman MA, Anglade D, Shamsaldeen F, Ahn S, Downs CA. Effectiveness of different music interventions on managing symptoms in cancer survivors: A meta-analysis. Eur J Oncol Nurs. 2021 Jun;52:101968. doi: 10.1016/j.ejon.2021.101968. Epub 2021 Apr 24.
PubMed 34020137

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT07481903
Acronym / sponsor ID: 7252224
Conditions: Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline), Pain, Insomnia, Anxiety, Fatigue, Depression
Keywords: Psychoneurological Symptom Cluster, Breast Cancer, Acupuncture
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 228 participants (estimated)
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
Study start: Apr 2026 (estimated)
Primary completion: Jun 2028 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 19 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EA group	Experimental	Device: electroacupunctureParticipants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks.
SA group	Sham comparator	Device: sham electroacupunctureParticipants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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).
Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
electroacupunctureA 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.	Device	EA group
sham electroacupunctureIn 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.	Device	SA group

Primary outcome

Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)
Time frame: Week 8
The response rate is defined as the proportion of participants classified as responders. Improvement in each of the six psychoneurological symptoms is assessed using the following validated instruments: pain is measured by the Visual Analogue Scale (VAS); sleep quality by the Pittsburgh Sleep Quality Index (PSQI); fatigue by the Chinese version of the Brief Fatigue Inventory (BFI-C); anxiety and depression by the Hospital Anxiety and Depression Scale (HADS); and subjective cognitive function by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). A participant is deemed a responder if the post treatment improvement from baseline meets or exceeds the minimum clinically important difference (MCID) for at least two of the six symptoms.

11 secondary outcomes

Response rate of psychoneurological symptom cluster (after 4 weeks of treatment and 12-week follow-up)
Time frame: Week 4, Week 12
Change from Baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Score
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12
Change from Baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Total and Subscale Scores
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12
Change from Baseline in the Visual Analogue Scale (VAS) Score for Cancer/Treatment-Related Pain
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Brief Fatigue Inventory-Chinese Version (BFI-C) Score
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) Score
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) Score
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Acupuncture Expectation Evaluation
Time frame: Within 5 minutes after the first treatment
Blinding assessment
Time frame: Within 5 minutes after the first treatment， Within 5 minutes after the last treatment
Safety Assessment
Time frame: The entire study period (Week 0 [Baseline] to Week 12 [Follow-up])

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Background: PubMed 37981982Lu 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.
Background: PubMed 38713422Kwon 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.
Background: PubMed 39858086Li 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.
Background: PubMed 36948325Liao 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.
Background: PubMed 34437474Cui 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.
Background: PubMed 38314195Sun 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.
Background: PubMed 32803635George 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.
Background: PubMed 36229337Li H, Lockwood MB, Schlaeger JM, Liu T, Danciu OC, Doorenbos AZ. Tryptophan and Kynurenine Pathway Metabolites and Psychoneurological Symptoms Among Breast Cancer Survivors. Pain Manag Nurs. 2023 Feb;24(1):52-59. doi: 10.1016/j.pmn.2022.09.002. Epub 2022 Oct 10.
Background: PubMed 36206160Grayson SC, Cummings MH, Wesmiller S, Bender C. The Cancer Genomic Integration Model for Symptom Science (CGIMSS): A Biopsychosocial Framework. Biol Res Nurs. 2023 Apr;25(2):210-219. doi: 10.1177/10998004221132250. Epub 2022 Oct 7.
Background: PubMed 32305573Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.
Background: PubMed 35739000Tong QY, Liu R, Gao Y, Zhang K, Ma W, Shen WD. Effect of Electroacupuncture Based on ERAS for Preoperative Anxiety in Breast Cancer Surgery: A Single-Center, Randomized, Controlled Trial. Clin Breast Cancer. 2022 Oct;22(7):724-736. doi: 10.1016/j.clbc.2022.04.010. Epub 2022 Apr 30.
Background: PubMed 37101228Zhang J, Qin Z, So TH, Chang TY, Yang S, Chen H, Yeung WF, Chung KF, Chan PY, Huang Y, Xu S, Chiang CY, Lao L, Zhang ZJ. Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial. Breast Cancer Res. 2023 Apr 26;25(1):49. doi: 10.1186/s13058-023-01645-0.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Shiyan Yan contact

+86 22 27986078

yanshiyan0927@sina.com

Ruihan Guo contact

+86 135 2033 6216

grh1882025@163.com

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shiyan Yan (+86 22 27986078, yanshiyan0927@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of psychoneurological symptom cluster (after 8 weeks of treatment) (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07481903, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.