An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)

Anhui Provincial Hospital1 个研究点分布在 1 个国家目标入组 490 人开始时间: 2023年12月1日最近更新: 2024年3月7日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 490
试验地点: 1
主要终点: IOF

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Through long-term dynamic monitoring of gynecologic malignant tumor patients undergoing early menopause after ovaries resection in our center, we explored the changes in menopausal symptoms and bone health status of this population, and studied the effects of platinum combined chemotherapy drugs on menopausal symptoms and bone loss in gynecologic malignant tumor patients. To find the optimal time point and effective regimen for MHT in gynecologic malignancies undergoing surgical menopause, and to provide guidance for osteoporosis screening and prevention strategies in women with gynecologic cancer.

详细描述

Gynecological malignancies are affecting the health of more and more women in the world, and the age of onset is also gradually younger. For women of reproductive age with gynecologic malignancies, surgery involving bilateral ovariectomy, followed by chemoradiotherapy or anti-estrogen therapy to maintain endocrine therapy, can lead to early menopause, leading to earlier and more severe menopausal syndrome and bone loss. Unlike the management of healthy women with natural menopause, the management of prognosis and quality of life in cancer patients with early menopause resulting from surgery combined with adjuvant therapy is more challenging and specific, and it is critical to identify management options for this complex patient population.

This study aims to conduct long-term dynamic monitoring of patients with gynecologic malignancies undergoing early menopause after ovaries resection in our center, explore the changes in menopausal symptoms and bone health status of this population, and study the effects of platinum combined chemotherapy drugs on menopausal symptoms and bone loss in patients with gynecologic malignancies. To find out the best time point and effective program of menopausal hormone therapy for gynecological malignant tumor patients with surgical menopause, and provide guidance for osteoporosis screening and prevention strategies for women with gynecological cancer.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Premenopausal women with gynecological malignancies aged 18-55 years old;
•Tumor types include endometrial cancer, cervical cancer, epithelial ovarian cancer;
•All patients received standard stage operation and treatment;
•Patients with bilateral ovaries resection; ⑤Voluntarily participate in this study, willing to sign informed consent, and have long-term follow-up conditions.

排除标准

•Menopause (women over 40 years of age stop menstruation for 12 months, excluding pregnancy and other diseases that may cause amenorrhea can be clinically diagnosed as menopause); Or AMH < 0.2ng/ml (China Menopause Management and Menopause Hormone Therapy Guidelines 2023 edition); Or FSH> 40 mIU/ml after two checks within one month;
•Other tumors were combined within 2 years and were still in radiotherapy, chemotherapy or hormone therapy;
•Diagnosis of immunodeficiency disease or active hepatitis B, C, active tuberculosis; ④Serious organic diseases of the organs, etc., can not cooperate with the study follow-up; ⑤Long-term use of hormonal drugs for rheumatic system diseases, such as glucocorticoids;
•Patients who have previously received pelvic or abdominal radiotherapy; ⑦ ECOG score ≥3 points; ⑧The patient did not sign informed consent or was unwilling to accept follow-up interviews.