Clinical trial NCT06151028: An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy
Official title: An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecological Malignancies
Menopausal Symptoms
Bone Loss
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-30
Enrollment: 490
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is an observational study. It is expected that the department will receive about 3000 patients with gynecologic malignancies in the next 10 years. Based on this, we plan to collect 490 premenopausal patients with gynecologic malignancies from the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) during 2023.12\~2033.12. All enrolled patients underwent standard tumor staging or tumor cell reduction involving bilateral ovariectomy and completed follow-up therapy (observation or chemotherapy) according to NCCN guidelines. The enrolled patients were followed up regularly for tumor risk assessment, menopause scale assessment, bone health assessment and related imaging examination. The medical history and data were complete.

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.

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.

Primary outcomes:
measure: Bone mineral density
timeFrame: Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation
measure: KMI
timeFrame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
measure: MENQOL
timeFrame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
measure: HADS
timeFrame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
measure: IOF
timeFrame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
measure: PSQI
timeFrame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.
Secondary outcomes:
measure: OS
timeFrame: 5 year
measure: PFS
timeFrame: 5 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Ying Zhou, MD
role: STUDY_CHAIR
References: