An observational study in Gynecological Malignancies, Menopausal Symptoms and Bone Loss, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Anhui Provincial Hospital · Observational
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 490 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
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This study is an observational study. It is expected that the department will receive about 3000 patients with gynecologic malignancies in the next 10 years. Based on this, we plan to collect 490 premenopausal patients with gynecologic malignancies from the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) during 2023.12\~2033.12. All enrolled patients underwent standard tumor staging or tumor cell reduction involving bilateral ovariectomy and completed follow-up therapy (observation or chemotherapy) according to NCCN guidelines. The enrolled patients were followed up regularly for tumor risk assessment, menopause scale assessment, bone health assessment and related imaging examination. The medical history and data were complete.
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;
Exclusion Criteria:
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;
This is an observational study and did not involve interventions.
Bone mineral density
Bone density examination
Time frame: Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation
KMI
Modified Kupperman Index（0-63score）
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
MENQOL
Menopause-Specific Quality of Life（0-174score）
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
HADS
Hospital Anxiety and Depression Scale（0-21score）
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
IOF
Osteoporosis Risk one-minute Test Scale (Yes or No)
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
PSQI
Pittsburgh sleep quality index（0-21score）
Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
OS
OS was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.
Time frame: 5 year
PFS
PFS is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
Time frame: 5 year
Plan to share: No
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Anhui Provincial Hospital