Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 18 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.

Locations
Other Locations
China
Obstetrics and Gynecology Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
WEIWEI SHAN, PhD
danweiwei7468@fckyy.org.cn
8613817813106
Backup
XIAOJUN CHEN, PhD
cxjlhjj@163.com
8613601680784
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 89
Treatments
Experimental: overweight 24kg/m2≤BMI<28kg/m2
MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management
Experimental: BMI≥28kg/m2
MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management
Related Therapeutic Areas
Sponsors
Leads: Xiaojun Chen

This content was sourced from clinicaltrials.gov

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