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

Phase

N/A

Condition

Bone Density

Osteoporosis

Perimenopause

Treatment

No intervention

Clinical Study ID

NCT06151028

Ying Zhou

Ages 18-55
Female
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Menopause (women over 40 years of age stop menstruation for 12 months, excludingpregnancy and other diseases that may cause amenorrhea can be clinically diagnosed asmenopause); Or AMH < 0.2ng/ml (China Menopause Management and Menopause HormoneTherapy 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, activetuberculosis; ④Serious organic diseases of the organs, etc., can notcooperate with the study follow-up; ⑤Long-term use of hormonal drugs forrheumatic 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 orwas unwilling to accept follow-up interviews.

Study Design

No intervention

December 01, 2023

December 31, 2033

Study 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.

Connect with a study center

Anhui Provincal Hospital
Hefei, Anhui
China
Active - Recruiting

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