Weight loss and hormone pill tested for fertility-sparing cancer treatment – but trial stopped early
NCT ID NCT05316467
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether combining weight management (diet and exercise guidance) with a daily hormone pill (megestrol acetate) could help obese patients with early-stage endometrial cancer who want to preserve their fertility. The goal was to see if the cancer would completely respond within 28 weeks. However, the trial was terminated early and only enrolled 8 people, so we cannot draw strong conclusions from it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Megestrol acetate (a hormone drug) plus intensive lifestyle intervention (diet and exercise guidance)
- What this could lead to
- If it had succeeded, this approach could have offered a way to control early endometrial cancer while preserving fertility in obese patients.
- What could go wrong
- The trial was terminated early with only 8 participants, so results are very limited. It is unclear if the combination works better than standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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8 people
The number who actually took part.
- Started
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May 2022
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011, China
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