Weight management and medication for early-stage endometrial cancer
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study
This study is testing if combining weight management and a medication called megestrol acetate can help obese women with early-stage endometrial cancer who want to keep their ability to have children.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 89 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05316467 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining weight management strategies with megestrol acetate treatment in obese women diagnosed with early-stage endometrioid carcinoma who wish to preserve their fertility. The approach includes intensive lifestyle interventions such as dietary control and exercise, alongside the administration of megestrol acetate, a high-dosage progesterone. The goal is to improve complete response rates and pregnancy outcomes in this patient population, addressing the impact of obesity on treatment efficacy. Participants will undergo thorough eligibility assessments, including imaging studies to confirm the absence of myometrial infiltration or extrauterine involvement.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 with a BMI of 24 kg/m² or higher, diagnosed with early endometrioid carcinoma, and seeking fertility preservation.
Not a fit: Patients who do not meet the age, BMI, or cancer diagnosis criteria, or those not interested in fertility preservation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes and fertility preservation for obese women with early-stage endometrial cancer.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly combining lifestyle interventions with progestin therapy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Obstetrics and Gynecology Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: XIAOJUN CHEN, PhD — Obstetrics & Gynecology Hospital of Fudan University
- Study coordinator: WEIWEI SHAN, PhD
- Email: danweiwei7468@fckyy.org.cn
- Phone: 8613817813106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.