Perimenopausal syndrome after endocrine therapy for breast cancer
Conditions
Interventions
treatment group:Traditional Chinese medicine treatment combined with conventional breast cancer treatment. According to clinical needs, zoledronic acid and calcium supplements are used.
control group:The placebo drug was combined with the routine breast cancer treatment. Zoledronic acid and calcium supplements were used as needed based on clinical requirements.
Sponsors
International Peace Maternal and Child Health Hospital Medical Research Ethics Committee
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Women who meet the diagnostic criteria for breast cancer and have not reached menopause before the surgery; 2) For those who meet the diagnostic criteria for perimenopausal syndrome of breast cancer according to the modified Kupperman score with a score > 6 and =30 that is patients with a mild or moderate menopausal state; 3) With or without HER-2 positivity; 4) No perimenopausal symptoms occurred before the treatment; 5) During the treatment period symptoms related to perimenopausal syndrome occurred and persisted for more than one month; 6) The patient is generally in good condition with good intelligence and mental state capable of normal language expression able to identify their own symptoms and cooperative in evaluating symptoms etc. 7) The expected survival period is more than one year; 8) Voluntarily sign the informed consent form to participate in the experimental study with good compliance and available for follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients who are pregnant or breastfeeding; 2) Patients who have reached menopause before the operation; 3) Patients with a Kupperman score 30 points (severe menopausal state); 4) There are plans for radiotherapy chemotherapy or surgery during the agreement period; 5) Those who are using other systemic phytoestrogens and/or antidepressants and have no intention of discontinuing the medication; 6) Patients with recurrence or metastasis shown by imaging or histology; 7) Patients with severe liver and kidney dysfunction severe cardiovascular and cerebrovascular diseases etc. 8) People with allergic constitutions and those allergic to known components of the test drug; 9) Currently participating in clinical trials of other drugs. 10) The patient is unwilling or unable to cooperate to complete the trial as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSQI;Gynecological ultrasound examination;PHQ-9;GAD-7;bone densitometry;Bone metabolism markers;SF-36;Pulse index;Tongue image indicators;Sex hormone level detection; | — |
Countries
China
Contacts
Public ContactGuozhiling
International Peace Maternal and Child Health Hospital Affiliated to Shanghai Jiaotong University Medical College
Outcome results
None listed