Monitoring menopausal symptoms in women with gynecological cancer after ovary removal
An Observational Study of Menopausal Symptom in Patients With Gynecological Malignancy After Oophorectomy (Carnation1)
This study looks at how menopause symptoms and bone health change over time in women aged 18-55 with gynecological cancer who have had their ovaries removed, to find the best ways to help them feel better and prevent bone loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Anhui Provincial Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06151028 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women aged 18-55 with gynecological malignancies who have undergone bilateral ovariectomy. It aims to monitor changes in menopausal symptoms and bone health over time, particularly the effects of platinum-based chemotherapy on these symptoms and bone loss. The study seeks to identify the optimal timing and effective regimens for menopausal hormone therapy in this unique patient population, providing guidance for osteoporosis screening and prevention strategies. By understanding these dynamics, the study aims to improve the quality of life for women facing early menopause due to cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18-55 with specific gynecological malignancies who have undergone surgery involving bilateral ovariectomy.
Not a fit: Patients who are already postmenopausal or have other concurrent tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of menopausal symptoms and bone health in women with gynecological cancers.
How similar studies have performed: While there is ongoing research in managing menopausal symptoms in cancer patients, this specific approach focusing on gynecological malignancies and early menopause is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- Anhui Provincal Hospital — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Ying Zhou, MD
- Email: caddiezy@ustc.edu.cn
- Phone: +8613865901025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.