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.
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；
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).
Parallel
electroacupuncture
DeviceA 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
DeviceIn 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.
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.
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.
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.
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.
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.
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