Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors

N/ANot Yet RecruitingNCT07481903

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine228 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

228

Conditions

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

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (6)

Senior Department of Oncology，Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Xiyuan Hospital of CACMS

Beijing, Beijing Municipality, China

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

Nanjing, Jiangsu, China

Qingdao Traditional Chinese Medicine Hospital, Qingdao Hiser Hospital Affiliated of Qingdao University

Qingdao, Shandong, China

Tianjin Medical University Cancer Institute & Hospital (TMUCIH)

Tianjin, Tianjin Municipality, China

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: Week 8

Secondary Outcomes

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.

Time frame: 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.

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

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.

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

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.