Breast cancer, insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for insomnia in breast cancer patients with yin deficiency and fire hyperactivity (1) Women aged = 18 years and = 75 years; (2) Patients diagnosed with primary breast malignant tumors have a clinical stage of I-III; (3) Prior to enrollment, corresponding radiotherapy, chemotherapy, or surgical treatment has been completed for at least 3 months, except for endocrine targeted therapy. (4) Meets the diagnostic criteria for chronic insomnia in ICSD-3; (5) Insomnia symptoms begin to appear within one week after surgery; (6) The traditional Chinese medicine syndrome differentiation is divided into yin deficiency and excessive fire type; (7) ISI>7 points (clinically significant insomnia); (8) It is allowed to take sleeping related drugs (barbiturates, chloral hydrate, tribromine mixture and hydroxyzine, benzodiazepine sedative and hypnotic drugs, zolpidem, zaleplon, zopiclone), and participants are not allowed to increase or change medication without consent during the study period. Throughout the entire study process, adjustments to medication and sleeping aids need to be notified to the researchers for detailed records; (9) Volunteer to participate in this project and sign an informed consent form. 2. Inclusion criteria for subjects undergoing multifunctional magnetic resonance imaging (fMRI) scanning (1) Meet all the criteria in 4.1, that is, meet the inclusion criteria for insomnia patients after breast cancer surgery with yin deficiency and fire hyperactivity; (2) Right-handed; (3) No organic brain lesions; (4) No contraindications for magnetic resonance imaging (such as metal implants, claustrophobia, etc.). (5) Within the first 3 months of entering this study, no sedative or hypnotic drugs were taken, and similar drugs and health products cannot be taken on their own during treatment and follow-up; (6) Volunteer to conduct a total of 2 multi-functional magnetic resonance scans and sign an informed consent form. 3. Inclusion criteria for healthy subjects (1) Women aged = 18 and = 75 years old; (2) Diagnosed and ruled out having tumors and tumor related complications; (3) Right-handed; (4) No system dysfunction; (5) No organic brain lesions; (6) No underlying diseases; (7) No bad habits such as smoking, drinking, special sleep, and eating; (8) No contraindications for magnetic resonance imaging (such as metal implants, claustrophobia, etc.); (9) ISI = 7 points (insomnia without clinical significance); (10) Voluntarily conduct a total of 1 multi-functional magnetic resonance imaging scan and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for insomnia patients after breast cancer surgery (1) Merge with other tumors; (2) Severe heart, liver, kidney, blood, respiratory system and other diseases; (3) Diagnosed as a mental illness patient according to the "Manual for Diagnosis and Statistics of Mental Disorders"; (4) Other types of sleep disorders, such as sleep apnea and restless legs syndrome (PSG shows sleep apnea hypopnea = 10/h or PSG shows periodic limb movements>15 times/h); Sleep disorders among shift workers; (5) Pregnant or lactating women; (6) Infectious diseases; (7) Those whose breast skin is broken to the point that they cannot accept acupuncture and moxibustion treatment; (8) Those who are afraid of needles or feel dizzy; (9) Participated in other projects within the past 3 months; (10) Severe visual, auditory, or language impairments; Individuals with unhealthy lifestyle habits such as alcohol or drug abuse; 2. Exclusion criteria for healthy subjects (1) Diagnosed as a mental illness patient according to the "Manual for Diagnosis and Statistics of Mental Disorders"; (2) Pregnant or lactating women; (3) Patients with infectious diseases; (4) Severe visual, auditory, or language impairments; Individuals with unhealthy lifestyle habits such as alcohol or drug abuse; (5) Other types of sleep disorders, such as sleep apnea, restless leg syndrome, and sleep disorders in shift workers; (6) Emotional disorders and lack of cooperation. (7) I have participated in other projects in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ISI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index,PSQI;polysomnography,PSG;Sleep Diary;Beck Anxiety Inventory,BAI;Beck Depression Inventory-II,BDI-II;fatigue score measured by the Chinese version of the Brief Fatigue Inventory,BFI-C;Functional Assessment of Cancer Therapy-Breast ,FACT-B;Traditional Chinese Medicine Syndrome Scale; CEA;estrogen; | — |
Countries
China
Contacts
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine