Menopausal syndrome associated with endocrine therapy in breast cancer
Conditions
Interventions
Placebo group:Placebo
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1)Female patients. (2)Patients who have undergone radical surgery for breast cancer with a pathological diagnosis of invasive breast cancer. (3)Pathological classification: Estrogen Receptor (ER) positive and/or Progesterone Receptor (PR) positive. (4)Postoperative staging from I to III. (5)Patients who have already undergone endocrine therapy for at least four weeks and are currently continuing this therapy. (6)Age between 18 and 85 years. (7)Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2. (8)Expected survival of at least 6 months. (9)No major organ dysfunction; cardiac hepatic and renal functions are essentially normal with laboratory test results meeting the following criteria: neutrophils > 1.5×109/L platelets > 100×109/L hemoglobin > 90g/L; total bilirubin within normal limits or < 1.5×Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5×ULN; serum creatinine < 1.5×ULN; endogenous creatinine clearance rate (Ccr) = 60 ml/min (calcula
Exclusion criteria
Exclusion criteria: (1)Patients with severe comorbidities such as significant neurological or psychiatric history including cognitive impairments that may affect the ability to understand and provide informed consent. (2)Patients undergoing concurrent radiotherapy with endocrine therapy. (3)Patients allergic to any of the medications used in this study. (4)Pregnant or breastfeeding women. (5)Individuals who have not signed the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Menopause Index (KMI) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Medication Compliance;TCM Constitutional Typing;TCM Syndrome Typing & Standardized Collection of Tongue and Pulse;Quality of Life Assessment: MD Anderson Symptom Inventory - Traditional Chinese Medicine Version (MDASI-TCM);Serum Estrogen Level Detection;Anxiety and Depression Scale; | — |
Countries
China
Contacts
Public ContactMopei Wang
Peking University Third Hospital
Outcome results
None listed