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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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.
Show all 9Show fewer
  • 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

Other trials in China

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.

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 groups in NCT05316467
Study groupRoleWhat they receive
overweight 24kg/m2≤BMI<28kg/m2ExperimentalMA+ 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/m2ExperimentalMA+ 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.

  1. 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)
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  1. First posted7 Apr 2022
  2. Study start1 May 2022
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Why it stopped: no enough enrolled patients

Resources

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)
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

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.

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