Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT03540251
Eligibility Criteria:
Inclusion Criteria:
* Primary breast cancer after surgical treatment, pathologically diagnosed malignant breast epithelial tumors (breast cancer), immunohistochemistry showed pathological type of estrogen receptor (ER) and / or progesterone receptor (PR) positive.
* Participants should be currently receiving endocrine therapy with oral administration of SERMS(selective estrogen receptor modulators) only.
* Participants should be suffered from perimenopausal symptoms,which is the sudden onset of facial skin flushing, sweating, began from chest and neck,often lasts a few seconds to several minutes and then subsided after center body temperature drops, the associated symptoms of heart palpitations, anxiety, impatience and even a sense of panic, and even wake up at night. The interval between the two attacks is more than 10 minutes.
* Hot flashes occurs during endocrine therapy of breast cancer
* KPS score \>60 score \>2 and ECOG
* Hot flashes (greater than or equal to 3 times the number of hot flashes per day)
* Symptoms persist for more than 2 weeks
Exclusion Criteria:
* Participants who have uncontrolled diabetes, hyperthyroidism and hypertension and in patients with pheochromocytoma
* Abnormal blood routine, liver and kidney damage (the index is greater than 1.2 times the upper limit of normal value)
* Pregnant or lactating women, persons with mental disorders
* Participants with other cancers
* Participants are participating in other clinical trials
* Current chemotherapy treatment period has not yet completed
* Taking corticosteroids or sex hormone treatment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT03540251
Study Brief:
Protocol Section:
NCT03540251