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

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a weight management program to megestrol acetate (a hormone treatment) improves outcomes for younger women with early-stage, low-grade uterine cancer (endometrioid carcinoma G1) who want to preserve their fertility. Standard treatment is hysterectomy, but some women wish to avoid this. **You may be eligible if...** - You are between 18 and 45 years old - Your BMI is 24 or higher (overweight or obese) - You have a confirmed diagnosis of grade 1 endometrioid endometrial carcinoma based on hysteroscopy or biopsy - Imaging shows no signs of cancer spreading beyond the uterus - You have already tried and failed progestin (progesterone-based) treatment as your first-line therapy **You may NOT be eligible if...** - Your cancer has spread to the muscle of the uterine wall or beyond - You have serious health conditions that prevent participation in weight management - You are pregnant or planning an immediate pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT05316467


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