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NCT Number: NCT06151028

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Anhui Provincal Hospital

Hefei, Anhui, China

Location status: Recruiting

Location contact

Ying Zhou

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study and did not involve interventions.

Primary outcomes

  1. Bone mineral density

    Time frame: Bone mineral density was followed up at 1, 2, 3, 6, 9, 12, 24 and 36 months after the operation

    Bone density examination

  2. KMI

    Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.

    Modified Kupperman Index(0-63score)

  3. MENQOL

    Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.

    Menopause-Specific Quality of Life(0-174score)

  4. HADS

    Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.

    Hospital Anxiety and Depression Scale(0-21score)

  5. IOF

    Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.

    Osteoporosis Risk one-minute Test Scale (Yes or No)

  6. PSQI

    Time frame: The scale was evaluated at 1, 3, 6 and 12 months after surgery.

    Pittsburgh sleep quality index(0-21score)

Secondary outcomes

  1. OS

    Time frame: 5 year

    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.

  2. PFS

    Time frame: 5 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhou, MD

CONTACT

[email protected]

+8613865901025

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Nov 30, 2023
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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