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NCT Number: NCT07481903

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.

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Key information

Conditions

Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline) Anxiety Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Dyssomnias Fatigue Insomnia Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Subjective Cognitive Decline (SCD)

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Senior Department of Oncology，Chinese PLA General Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

：

  • 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 criteria

  • 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.
  • 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.

Treatment and study plan

Electroacupuncture

Device

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 electroacupuncture

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruihan Guo

CONTACT

[email protected]

+86 135 2033 6216

Shiyan Yan

CONTACT

[email protected]

+86 22 27986078

Sponsors and collaborators

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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