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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT05613504
Eligibility Criteria:
Inclusion Criteria:
* Aged 30-75 years old;
* Adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or without ovarian function suppression has been administered for at least 4 weeks and is currently on treatment;
* Patients with persistent hot flashes for at least 4 weeks and with a frequency of more than 14 hot flashes per week (2 times per day) in the week before inclusion in the study, the weekly average hot flash composite score is 3-4;
* Patients after surgery and chemotherapy (if any);
* Eastern Cooperative Oncology Group score of 0-1 points.
* Sign the informed consent and participate in the clinical observation voluntarily.
Exclusion Criteria:
* Tumor metastases, undergoing chemoradiotherapy or planning surgery;
* Pharmacological intervention for hot flashes with hot flash treatment drugs such as selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants for at least 4 weeks prior to study initiation;
* Patients receiving phytoestrogens, tibolone or analogs, verapril, or specific homeopathic medicines;
* Started or changed adjuvant hormone therapy within the past week, or who planned to start or change adjuvant hormone therapy in the past 14 weeks, pregnant or breastfeeding patients;
* Bleeding or coagulation disorders with obvious uncontrolled infection
* Psychiatric illness or family history; neurological disorder or family history; seizure possibility or history of seizures.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05613504
Study Brief:
Protocol Section:
NCT05613504