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Recruiting Observational

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

NCT06151028 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-12-01
Last updated
2024-03-07

Condition(s) studied

Gynecological MalignanciesMenopausal SymptomsBone Loss

Investigational drug(s) / intervention(s)

No intervention

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

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

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Bone mineral density — Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation
    Bone density examination
  • KMI — The scale was evaluated at 1, 3, 6 and 12 months after surgery.
    Modified Kupperman Index(0-63score)
  • MENQOL — The scale was evaluated at 1, 3, 6 and 12 months after surgery.
    Menopause-Specific Quality of Life(0-174score)
  • HADS — The scale was evaluated at 1, 3, 6 and 12 months after surgery.
    Hospital Anxiety and Depression Scale(0-21score)
  • IOF — The scale was evaluated at 1, 3, 6 and 12 months after surgery.
    Osteoporosis Risk one-minute Test Scale (Yes or No)
  • PSQI — The scale was evaluated at 1, 3, 6 and 12 months after surgery.
    Pittsburgh sleep quality index(0-21score)

Trial sites (1)

FacilityCityRegionStatus
Anhui Provincal Hospital Hefei Anhui Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06151028 on ClinicalTrials.gov ↗ ← All trials in China