Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma

Launched by XIAOJUN CHEN · Apr 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a combination of weight management and a medication called megestrol acetate is for women who are overweight or obese and have early-stage endometrial carcinoma, which is a type of cancer in the lining of the uterus. The goal is to see if this approach can help these women preserve their fertility while treating their cancer. The trial is currently recruiting participants aged between 18 and 45 who have a body mass index (BMI) of 24 or higher and have been diagnosed with early-stage endometrial carcinoma.

Eligible participants will need to have a confirmed diagnosis through a biopsy and will undergo imaging tests to ensure their cancer is in the early stages and hasn't spread. They should also be motivated to preserve their ability to have children. Throughout the trial, participants will receive support for weight management alongside the medication, and they will need to commit to regular follow-ups at Fudan University’s Obstetrics and Gynecology Hospital. This trial offers an opportunity for women seeking fertility preservation options while managing their cancer treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years≤age≤45years
• • 2. BMI (body mass index) ≥24kg/m2
• • 3. Consent informed and signed
• • 4. Pathologically confirmed as endometrial carcinoma Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrioid carcinoma, G1. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
• • 5. Imaging Assessment Enhanced MRI of the pelvis and enhanced CT of the upper abdomen must be performed in 2 weeks prior to starting treatment to assess the lesions confined to the endometrial layer without clear myometrial infiltration or extrauterine involvement.
• • 6. Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
• • 7. Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.
• Exclusion Criteria:
• • 1. Patients with non-endometrioid endometrial carcinoma, endometrioid endometrial carcinoma G2/G3 or other malignant tumors of the reproductive system; imaging suggests myometrial invasion, cervical involvement or extra-uterine involvement.
• • 2. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevate to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \<30 mL/min)
• • 3. Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.
• • 4. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
• • 5. Those who require hysterectomy or other methods other than conservative treatment.
• • 6. Known or suspected pregnancy.
• • 7. Those who has contraindications to use progestin.
• • 8. Deep vein thrombosis, stroke, myocardial infarction.
• • 9. Severe joint lesions that prevent walking or movement.