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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06151028
Other study ID # Ying Zhou
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2033

Study information

Verified date October 2023
Source Anhui Provincial Hospital
Contact Ying Zhou, MD
Phone +8613865901025
Email caddiezy@ustc.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
No intervention
This is an observational study and did not involve interventions.

Locations

Country Name City State
China Anhui Provincal Hospital Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

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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