Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma

NCT05316467 | Recruiting Phase 2

• 1 other identifier: 53211036-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma（EEC）asking for fertility-sparing treatment

Conditions

Endometrial Carcinoma; Obese; Overweight; Fertility Issues

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (CR) rates

  The 28-week CR rates will be calculated in two arms

  From date of recruitment until the date of CR, assessed up to 28 weeks.

Secondary Outcomes (15)

• Pregnancy outcomes

  up to 2 years after complete response of the last participant

• Weight change

  From date of recruitment, assessed up to 28 weeks.

• Change of body composition

  From date of recruitment, assessed up to 28 weeks.

• Change of heart rates

  From date of recruitment, assessed up to 28 weeks.

• Change of blood pressures

  From date of recruitment, assessed up to 28 weeks.

Study Arms (2)

overweight 24kg/m2≤BMI<28kg/m2

EXPERIMENTAL

MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management

Behavioral: Intensive Lifestyle Intervention (ILI); Drug: Megestrol Acetate 160 MG Oral Tablet

BMI≥28kg/m2

EXPERIMENTAL

MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management

Behavioral: Intensive Lifestyle Intervention (ILI); Drug: Megestrol Acetate 160 MG Oral Tablet

Interventions

Intensive Lifestyle Intervention (ILI) BEHAVIORAL

* dietary guidance * exercise guidance * lifestyle intervention

Also known as: Weight Management

BMI≥28kg/m2; overweight 24kg/m2≤BMI<28kg/m2

Megestrol Acetate 160 MG Oral Tablet DRUG

enrolled participants will take Megestrol Acetate 160mg daily

Also known as: yilizhi

BMI≥28kg/m2; overweight 24kg/m2≤BMI<28kg/m2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaojun Chen: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Obesity; Overweight; Infertility

Interventions

Megestrol Acetate; Tablets

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• XIAOJUN CHEN, PhD

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WEIWEI SHAN, PhD

CONTACT

8613817813106; danweiwei7468@fckyy.org.cn

XIAOJUN CHEN, PhD

CONTACT

8613601680784; cxjlhjj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.PhD. Vice president of Obstetrics & Gynecology Hospital of Fudan University

Model Details: All enrolled patients will receive enhanced lifestyle management to control weight and take Megestrol Acetate (MA) for treating EEC.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 7, 2022
• Study Start: May 1, 2022
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)