Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07481903
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07481903
Study Brief:
Protocol Section:
NCT07481903