Chinese Herbal Medicines for Menopausal Symptoms in Breast Cancer Patients: A Randomized, Double-blind, Controlled Study
- Conditions
- Menopause, Breast cancer
- Registration Number
- ITMCTR1900002360
- Lead Sponsor
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
? 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.
? 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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Greene Scale;
- Secondary Outcome Measures
Name Time Method HFRDIS;QLQ-BR23;