Breast cancer endocrine therapy-induced insomnia after treatment
Conditions
Interventions
Experimental Group:Treatment with Qiangxi Rehmannia Decoction combined with sleep health education. Composition of the formula: Qiangxi Rehmannia Decoction (Rehmannia glutinosa 30g, Stephania tetrandr
Control Group:Sleep Health Education and Therapy. Through online video learning, gain knowledge about sleep health and establish good sleep hygiene habits.
Sponsors
Beijing University of Chinese Medicine Third Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Female, aged between 18 and 75 years (including 18 and 75 years); (2) Patients diagnosed with hormone-dependent breast cancer by postoperative pathology and immunohistochemistry; (3) Have received endocrine therapy for at least 3 months and experienced insomnia or worsening of insomnia after endocrine therapy; (4) Chinese medicine diagnosis of yin deficiency with hyperactivity of fire syndrome; (5) Insomnia Severity Index (ISI) = 8 points; (6) Karnofsky Performance Status (KPS) score = 70 points; (7) Possess a smartphone and have a certain ability to understand and express; (8) Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe anxiety, depression, or other mental disorders causing sleep disorders; (2) Meeting diagnostic criteria for other sleep disorders, such as obstructive sleep apnea, restless legs syndrome, or REM sleep behavior disorder; (3) Use of hypnotic medications for treatment within the past month; (4) Alcohol and/or other substance abuse or dependence; (5) History of allergies, or previous allergic reactions to Chinese medicine; (6) Receipt of other anti-tumor treatment measures outside of this protocol; (7) Subjects expected to experience worsening or progression of breast cancer during the study period and require other treatments; (8) Presence of other malignancies or severe impairment of cardiac, hepatic, or renal function (laboratory indicators exceeding twice the upper limit of normal values); (9) Severe comorbidities, active infections, severe bleeding tendencies, or abnormal hematopoietic function; (10) Pregnant or breastfeeding women, or fertile females unwilling to adopt effective contraceptive measures throughout the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Scale;Traditional Chinese Medicine Symptom Scoring;Breast Cancer Patients Quality of Life Instrument (FACT-B);Functional Assessment of Cancer Therapy - Endocrine Symptoms Subscale;Hospital Anxiety and Depression Scale;Sleep Diary; | — |
Countries
China
Contacts
Public ContactXiaohua Pei
Beijing University of Chinese Medicine Third Affiliated Hospital
Outcome results
None listed