Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors

March 15, 2026 updated by: Yan Shiyan, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100039
        • Senior Department of Oncology，Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Shaohua Zhang, PhD
      • Beijing, Beijing Municipality, China, 100091
        • Xiyuan Hospital of CACMS
        • Contact:
        • Principal Investigator:
          • ZhongNing Guo, PhD
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
        • Contact:
        • Principal Investigator:
          • Jing Lu, PhD
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Qingdao Traditional Chinese Medicine Hospital, Qingdao Hiser Hospital Affiliated of Qingdao University
        • Contact:
        • Principal Investigator:
          • Bo Liu, PhD
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital (TMUCIH)
        • Contact:
        • Principal Investigator:
          • Bin Wang, PhD
      • Tianjin, Tianjin Municipality, China, 300381
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • FanMing Kong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EA group
Participants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks.
Device: 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 Comparator: SA group
Participants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of psychoneurological symptom cluster (after 4 weeks of treatment and 12-week follow-up)
Time Frame: Week 4, Week 12
The definition and calculation method of the response rate are consistent with those of the primary outcome measure.
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
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.
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
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.
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
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.
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
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.
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
The BFI-C consists of 9 items. Its total score ranges from 0 to 10, with higher scores indicating greater fatigue.
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
The HADS-A consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe anxiety.
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
The HADS-D consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe depression.
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
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.
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
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.
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])
The occurrence of acupuncture-related and general adverse events (including serious adverse events [SAEs]) is documented in detail throughout the study.
The entire study period (Week 0 [Baseline] to Week 12 [Follow-up])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7252224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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