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

NCT ID: NCT06151028

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 490 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2033-12-31

Brief 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.

Detailed 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.

Conditions

Gynecological Malignancies; Menopausal Symptoms; Bone Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

This is an observational study and did not involve interventions.

Intervention Type: OTHER

Eligibility Criteria

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; ⑤Voluntarily 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; 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Zhou, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

Anhui Provincal Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Zhou, MD

Role: CONTACT

caddiezy@ustc.edu.cn

+8613865901025

Facility Contacts

Ying Zhou

Role: primary

caddie1234@gmail.com

Other Identifiers

Ying Zhou

Identifier Type: -

Identifier Source: org_study_id