Bone Loss Clinical Trial
Official title:
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)
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.
Status | Recruiting |
Enrollment | 490 |
Est. completion date | December 31, 2033 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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; ?Voluntarily participate in this study, willing to sign informed consent, and have long-term follow-up conditions. 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; ?Serious organic diseases of the organs, etc., can not cooperate with the study follow-up; ?Long-term use of hormonal drugs for rheumatic system diseases, such as glucocorticoids; - Patients who have previously received pelvic or abdominal radiotherapy; ? ECOG score =3 points; ?The patient did not sign informed consent or was unwilling to accept follow-up interviews. |
Country | Name | City | State |
---|---|---|---|
China | Anhui Provincal Hospital | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Anhui Provincial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density | Bone density examination | Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation | |
Primary | KMI | Modified Kupperman Index(0-63score) | The scale was evaluated at 1, 3, 6 and 12 months after surgery. | |
Primary | MENQOL | Menopause-Specific Quality of Life(0-174score) | The scale was evaluated at 1, 3, 6 and 12 months after surgery. | |
Primary | HADS | Hospital Anxiety and Depression Scale(0-21score) | The scale was evaluated at 1, 3, 6 and 12 months after surgery. | |
Primary | IOF | Osteoporosis Risk one-minute Test Scale (Yes or No) | The scale was evaluated at 1, 3, 6 and 12 months after surgery. | |
Primary | PSQI | Pittsburgh sleep quality index(0-21score) | The scale was evaluated at 1, 3, 6 and 12 months after surgery. | |
Secondary | 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. | 5 year | |
Secondary | 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. | 5 year |
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