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

Bone Loss Clinical Trial

Official title:

An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151028
• Other study ID #: Ying Zhou
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bone Loss
• Gynecological Malignancies
• Menopausal Symptoms
• Neoplasms

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