Menopause, Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? Patients with primary breast cancer (stage 0-III) by pathologic diagnosis and with menopausal symptoms; ? Aged 25-60 years; ? Patients are undergoing endocrine therapy for more than 3 months; ? The subjects experienced at least 4 times of moderate and severe hot flashes every day; ? The Karnofsky score is greater than or equal to 60 points; ? The predicted survival time is greater than or equal to 6 months; ? Voluntarily sign the informed consent file.
Exclusion criteria
Exclusion criteria: ? Patients with recurrent, metastatic breast cancer or other cancer diagnosed by imaging or histology; ? Patients who cannot adhere to endocrine therapy; ? Uncontrolled and/or diagnosed medical conditions such as severe liver, kidney, heart, and brain diseases; abnormal bone marrow function; Uncontrolled or untreated hypertension (SBP >160mmHg and/or DBP > 100mmHg), Uncontrolled or untreated diabetes; Or abnormal thyrotropin may lead to symptoms similar to menopausal symptoms. ? Pregnant and lactating women; ? Participated in phase I and II clinical trials in the past 6 months or participated in phase III and IV clinical trials in 3 months; ? Use other medications (e.g. tibolone, black cohosh extract or soy isoflavones, vitamins, etc.) for menopausal symptoms within 3 months; ? Allergic to the tested drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Greene Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| HFRDIS;QLQ-BR23; | — |
Countries
China
Contacts
he Second Affiliated Hospital of Guangzhou University of Chinese Medicine