Endometrial CarcinomaPhase 2/3NCT05316467
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma
A Phase 2/3 study testing Intensive Lifestyle Intervention (ILI) and Megestrol Acetate 160 MG Oral Tablet in people with Endometrial Carcinoma and Obese, run by Xiaojun Chen at 1 site in China.
Trial summary
To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma(EEC)asking for fertility-sparing treatment Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Carcinoma, Obese, Overweight
- What is being tested?
- Intensive Lifestyle Intervention (ILI) and Megestrol Acetate 160 MG Oral Tablet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 28 Feb 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Those who has contraindications to use progestin.
- Deep vein thrombosis, stroke, myocardial infarction.
- Severe joint lesions that prevent walking or movement.
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study
To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma(EEC)asking for fertility-sparing treatment
Read the detailed description
Background:
High-dosage high-efficacy progesterone, such as Megestrol Acetate (MA) and medroxyprogesterone acetate(MPA), is still the first-line treatment for women with early endometrioid endometrial cancer (EEC) who want to preserve fertility. Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). Overweight/obesity is an independent risk factor for fertility-sparing treatment response and pregnant outcomes in young females with early endometrioid cancer, substantial evidence showed that obesity can cause relatively lower complete response(CR)rates, longer time to achieve completer remission and lower birth rates besides metabolic disorders and other adverse effects caused by obesity. Weight management has been found to improve metabolic disorders, ovarian functions and pregnant outcomes.The hypothesize is that weight management plus progestin therapy may raise CR rates and pregnant outcomes in young female EEC patients asking for fertility conservation. Previous research has shown that metformin plus MA can increase CR rates. Enhanced lifestyle management (diet control, exercise and daily behavioral guidance) may improve metabolic conditions, increase CR rates and pregnant outcomes in obese EEC patients who want to preserve fertility. Till now, no similar studies were found, so the investigators design this study to explore the efficacy of weight control in EEC fertility-sparing patients to provide new evidence for improving conservative treatment.
Objective: To investigate whether weight management plus MA improve the efficacy of preserving fertility when compared to MA alone in obese women with EEC who want fertility conservation.
Design: This study is two single-arm, prospective, open-label. Patients with early-stage endometrioid carcinoma requiring conservation treatment with BMI ≥ 24 kg/m2 will be recruited in this study and they will be divided into two arms, one is overweight group (24kg/m2≤BMI<28kg/m2) and another is obese group (BMI≥28kg/m2). Each arm and its sample size was designed according to Simon's Two-Stage Design. All enrolled patients will receive enhanced lifestyle management to control weight and take MA for treating EEC. Hysteroscopic examination, metabolic and inflammatory indicators will be performed every 12 to16 weeks while other indexes will be evaluated every month, including weight, heart rates,blood pressure and so on.For the progestin efficacy evaluation, CR is defined as the remission of EEC to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia with or without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as disease progression in patients. Two months' maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.
Outcomes: Primary outcome is the CR rates of the two arms (overweight and obesity group). Secondary outcomes include pregnancy rates, live birth rates, weight loss, insulin resistance, chronic inflammation indicators, time to achieve CR and the recurrence rates and so on. Safety and side events during the whole trial will be monitored in two years.
- Conditions
- Endometrial Carcinoma, Obese, Overweight, Fertility Issues
- Being tested
- Intensive Lifestyle Intervention (ILI), Megestrol Acetate 160 MG Oral Tablet
- Medical subject headings
- Endometrial Neoplasms, Obesity, Overweight, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle Intervention (ILI)Behavioural
Also called Weight Management
- dietary guidance
- exercise guidance
- lifestyle intervention
Megestrol Acetate 160 MG Oral TabletDrug
Also called yilizhi
enrolled participants will take Megestrol Acetate 160mg daily
| Study group | Role | What they receive |
|---|---|---|
| overweight 24kg/m2≤BMI<28kg/m2 | Experimental | MA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management Receives: 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 Receives: Behavioral: Intensive Lifestyle Intervention (ILI); Drug: Megestrol Acetate 160 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (CR) rates
The 28-week CR rates will be calculated in two arms
Measured: From date of recruitment until the date of CR, assessed up to 28 weeks.
Secondary outcomes (15)
Pregnancy outcomes
For patients have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period.
Measured: up to 2 years after complete response of the last participant
Weight change
Body weight will be recorded every month and compare its change during the trial in kilograms.
Measured: From date of recruitment, assessed up to 28 weeks.
Change of body composition
Assess the improvement of body composition, the investigators will detect body composition with InBody machine and calculate changes of the indicated indexes.
Measured: From date of recruitment, assessed up to 28 weeks.
Change of heart rates
Record heart rates in bpm (beats per minute) every 12-16 weeks and calculate its change during the trial.
Measured: From date of recruitment, assessed up to 28 weeks.
Change of blood pressures
Record blood pressure (both of systolic and diastolic pressures) every 12-16 weeks and compare its change during the treatment.
Measured: From date of recruitment, assessed up to 28 weeks.
Blood glucose change
Assess fasting glucose levels each 3 to 4 months and calculate changes during the trial in mmol/L.
Measured: From date of recruitment, assessed up to 28 weeks.
Blood lipids change
Assess blood lipids levels each 3 to 4 months and compare their change during the treatment.
Measured: From date of recruitment, assessed up to 28 weeks.
Insulin resistance change
Assess fasting insulin levels each 3 to 4 months and compare their changes during the trial.
Measured: From date of recruitment, assessed up to 28 weeks.
Ovarian reserve function change
Detect serum Anti-Mullerian Hormone (AMH) levels each 3 or 4 months and calculate its change.
Measured: From date of recruitment, assessed up to 28 weeks.
Quality of life change
Collect quality of life questionnaire (SF-36 and IWQOL-LITE) every 12-16 weeks and count scores.
Measured: From date of recruitment, assessed up to 28 weeks.
Physical activities change
Collect physical activities questionnaire(IPAQ)and compare scores changes through conservative treatment.
Measured: From date of recruitment, assessed up to 28 weeks.
Chronic inflammatory indexes change
Detect chronic inflammatory indexes, including TNF-α(tumor necrosis factor), IL-1 and IL-6, and calculate changes through the whole treatment period.
Measured: From date of recruitment, assessed up to 28 weeks.
Time of pathological complete response (CR)
Time of histologic regression from EC to proliferative or secretory endometrium
Measured: From date of recruitment until the date of CR, assessed up to 2 years.
Incidence of adverse events
Adverse events related with MA and weight control. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.
Measured: From date of recruitment until the date of CR, assessed up to 2 years.
Relapse rates
All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then the investigators can get the relapse rates. Comparison will be performed between two groups.
Measured: up to 2 years after the treatment for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2022
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Why it stopped: no enough enrolled patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled patients will receive enhanced lifestyle management to control weight and take Megestrol Acetate (MA) for treating EEC.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaojun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaojun Chen, Fudan University
- Investigators
- XIAOJUN CHEN, PhD, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316467
- Sponsor's protocol ID
- 53211036-01
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma: Two Single-arm, Prospective and Open-label Clinical Study
- ClinicalTrials.gov ID
- NCT05316467
- Acronym / sponsor ID
- 53211036-01
- Conditions
- Endometrial Carcinoma, Obese, Overweight, Fertility Issues
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no enough enrolled patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Xiaojun ChenUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma(EEC)asking for fertility-sparing treatment
Detailed description
Background:
High-dosage high-efficacy progesterone, such as Megestrol Acetate (MA) and medroxyprogesterone acetate(MPA), is still the first-line treatment for women with early endometrioid endometrial cancer (EEC) who want to preserve fertility. Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). Overweight/obesity is an independent risk factor for fertility-sparing treatment response and pregnant outcomes in young females with early endometrioid cancer, substantial evidence showed that obesity can cause relatively lower complete response(CR)rates, longer time to achieve completer remission and lower birth rates besides metabolic disorders and other adverse effects caused by obesity. Weight management has been found to improve metabolic disorders, ovarian functions and pregnant outcomes.The hypothesize is that weight management plus progestin therapy may raise CR rates and pregnant outcomes in young female EEC patients asking for fertility conservation. Previous research has shown that metformin plus MA can increase CR rates. Enhanced lifestyle management (diet control, exercise and daily behavioral guidance) may improve metabolic conditions, increase CR rates and pregnant outcomes in obese EEC patients who want to preserve fertility. Till now, no similar studies were found, so the investigators design this study to explore the efficacy of weight control in EEC fertility-sparing patients to provide new evidence for improving conservative treatment.
Objective: To investigate whether weight management plus MA improve the efficacy of preserving fertility when compared to MA alone in obese women with EEC who want fertility conservation.
Design: This study is two single-arm, prospective, open-label. Patients with early-stage endometrioid carcinoma requiring conservation treatment with BMI ≥ 24 kg/m2 will be recruited in this study and they will be divided into two arms, one is overweight group (24kg/m2≤BMI<28kg/m2) and another is obese group (BMI≥28kg/m2). Each arm and its sample size was designed according to Simon's Two-Stage Design. All enrolled patients will receive enhanced lifestyle management to control weight and take MA for treating EEC. Hysteroscopic examination, metabolic and inflammatory indicators will be performed every 12 to16 weeks while other indexes will be evaluated every month, including weight, heart rates,blood pressure and so on.For the progestin efficacy evaluation, CR is defined as the remission of EEC to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia with or without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as disease progression in patients. Two months' maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.
Outcomes: Primary outcome is the CR rates of the two arms (overweight and obesity group). Secondary outcomes include pregnancy rates, live birth rates, weight loss, insulin resistance, chronic inflammation indicators, time to achieve CR and the recurrence rates and so on. Safety and side events during the whole trial will be monitored in two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All enrolled patients will receive enhanced lifestyle management to control weight and take Megestrol Acetate (MA) for treating EEC.
| Arm | Type | Receives |
|---|---|---|
| overweight 24kg/m2≤BMI<28kg/m2 | Experimental | Behavioral: Intensive Lifestyle Intervention (ILI), Drug: Megestrol Acetate 160 MG Oral TabletMA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management |
| BMI≥28kg/m2 | Experimental | Behavioral: Intensive Lifestyle Intervention (ILI), Drug: Megestrol Acetate 160 MG Oral TabletMA+ weight management enrolled patients will receive megestrol acetate 160mg po qd plus weight management |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Lifestyle Intervention (ILI)Also: Weight Management* dietary guidance * exercise guidance * lifestyle intervention | Behavioural | BMI≥28kg/m2, overweight 24kg/m2≤BMI<28kg/m2 |
| Megestrol Acetate 160 MG Oral TabletAlso: yilizhienrolled participants will take Megestrol Acetate 160mg daily | Drug | BMI≥28kg/m2, overweight 24kg/m2≤BMI<28kg/m2 |
Primary outcome
Pathological complete response (CR) rates
Time frame: From date of recruitment until the date of CR, assessed up to 28 weeks.
The 28-week CR rates will be calculated in two arms
15 secondary outcomes
Pregnancy outcomes
Time frame: up to 2 years after complete response of the last participant
Weight change
Time frame: From date of recruitment, assessed up to 28 weeks.
Change of body composition
Time frame: From date of recruitment, assessed up to 28 weeks.
Change of heart rates
Time frame: From date of recruitment, assessed up to 28 weeks.
Change of blood pressures
Time frame: From date of recruitment, assessed up to 28 weeks.
Blood glucose change
Time frame: From date of recruitment, assessed up to 28 weeks.
Blood lipids change
Time frame: From date of recruitment, assessed up to 28 weeks.
Insulin resistance change
Time frame: From date of recruitment, assessed up to 28 weeks.
Ovarian reserve function change
Time frame: From date of recruitment, assessed up to 28 weeks.
Quality of life change
Time frame: From date of recruitment, assessed up to 28 weeks.
Physical activities change
Time frame: From date of recruitment, assessed up to 28 weeks.
Chronic inflammatory indexes change
Time frame: From date of recruitment, assessed up to 28 weeks.
Time of pathological complete response (CR)
Time frame: From date of recruitment until the date of CR, assessed up to 2 years.
Incidence of adverse events
Time frame: From date of recruitment until the date of CR, assessed up to 2 years.
Relapse rates
Time frame: up to 2 years after the treatment for each patient
Results and safety
The study was stopped early (reason given: no enough enrolled patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XIAOJUN CHEN, PhD principal investigator
Obstetrics & Gynecology Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intensive Lifestyle Intervention (ILI) and Megestrol Acetate 160 MG Oral Tablet in people with Endometrial Carcinoma and Obese, run by Xiaojun Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no enough enrolled patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (CR) rates (time frame: From date of recruitment until the date of CR, assessed up to 28 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.