RecruitingPhase 2Phase 3NCT05316467
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study
Sponsor
Xiaojun Chen
Enrollment
89 participants
Start Date
May 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma（EEC）asking for fertility-sparing treatment
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria7
- years≤age≤45years
- BMI (body mass index) ≥24kg/m2
- Consent informed and signed
- 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.
- 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.
- Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
- 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 Criteria9
- 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.
- 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)
- 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.
- Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
- Those who require hysterectomy or other methods other than conservative treatment.
- Known or suspected pregnancy.
- Those who has contraindications to use progestin.
- Deep vein thrombosis, stroke, myocardial infarction.
- Severe joint lesions that prevent walking or movement.
Interventions
BEHAVIORALIntensive Lifestyle Intervention (ILI)
* dietary guidance * exercise guidance * lifestyle intervention
DRUGMegestrol Acetate 160 MG Oral Tablet
enrolled participants will take Megestrol Acetate 160mg daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05316467
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