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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Loss; Menopausal Symptoms; Gynecological Malignancies
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Ying Zhou, MD; Phone Number: +8613865901025; Email: caddiezy@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincal Hospital
      • Contact: Ying Zhou; Email: caddie1234@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
KMI	Modified Kupperman Index（0-63score）	The scale was evaluated at 1, 3, 6 and 12 months after surgery.
MENQOL	Menopause-Specific Quality of Life（0-174score）	The scale was evaluated at 1, 3, 6 and 12 months after surgery.
HADS	Hospital Anxiety and Depression Scale（0-21score）	The scale was evaluated at 1, 3, 6 and 12 months after surgery.
IOF	Osteoporosis Risk one-minute Test Scale (Yes or No)	The scale was evaluated at 1, 3, 6 and 12 months after surgery.
PSQI	Pittsburgh sleep quality index（0-21score）	The scale was evaluated at 1, 3, 6 and 12 months after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Study Chair: Ying Zhou, MD, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Ying Zhou

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No