Breast Cancer
Conditions
Interventions
Sponsors
Chengdu Pidu District Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Female aged 18–75 years; 2) Diagnosed with breast cancer stage 0–III (TNM staging) according to the Chinese Guidelines for Diagnosis and Treatment of Common Malignant Tumors; 3) Meeting diagnostic criteria for insomnia with comorbid anxiety or depression as defined by the Chinese Classification of Mental Disorders, 3rd Edition (CCMD-3) or the International Classification of Diseases, 10th Revision (ICD-10), with an Insomnia Severity Index (ISI) score >8; 4) Expected survival period >6 months; 5) Karnofsky Performance Status (KPS) score >60; 6) No use of medications that may interfere with efficacy evaluation within one week prior to enrollment; 7) Conscious, capable of effective communication, able to complete assessments as scheduled, and having voluntarily signed the informed consent form. Participants must fulfill all the above criteria to be included.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Local infection or severe skin lesions at acupuncture points. 3. Platelet count <50×10^9/L. 4. History of needle syncope. 5. Severe dysfunction of major organs (e.g., heart, liver, kidneys) or psychiatric disorders. 6. Secondary insomnia resulting from severe cancer pain, tumor-induced airway obstruction, or related somatic symptoms. 7. Planned surgery during the trial period. 8. Alcohol or other substance abuse/dependence. 9. Concurrent participation in other clinical studies. 10. Long-term night-shift work or irregular sleep-wake patterns. Participants meeting any one of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30++Breast Cancer Module 23;Self-Rating Depression Scale;Self-Rating Anxiety Scale;Consensus Sleep Diary;State-Trait Anxiety Inventory;Depression, Anxiety and Stress Scale;Mini-Mental Adjustment to Cancer Scale;Profile of Mood States ;Brief Pain Inventory - Short Form;Traditional Chinese Medicine Clinical Symptom Score Scale; | — |
Countries
China
Contacts
Public ContactLi Ying
Chengdu University of Tradirional Chinese Medicine
Outcome results
None listed