Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    48
  • sponsor
    Fudan University
Updated on 7 October 2022

Summary

To explore the treatment efficacy of megestrol acetate plus rosuvastatin in patients with early endometrial carcinoma (EEC) seeking for conservative treatment.

Description

After diagnosed of EEC by hysteroscopy, patients meet the study criteria will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels, anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 520.

Patients will receive MA (megestrol acetate) 160 mg by mouth daily plus rosuvastatin 10mg by mouth daily for at least 6 months. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR or NR. Patients with PD will be recommended for hysterectomy.

Due to personal reasons, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months. For patients remained SD after 6 to 8 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given.

Two months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

Details
Condition Endometrial Carcinoma Stage I
Treatment Rosuvastatin, Megestrol Acetate
Clinical Study IdentifierNCT04491643
SponsorFudan University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
Have a desire for remaining reproductive function or uterus
Good compliance with adjunctive treatment and follow-up
Abnormal blood lipid. At least meet one of the following five items
Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)
Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)
High-density lipoprotein cholesterol (HDL-C) #1.03mmol/L (40mg/dL)
Apo-lipoprotein-A (Apo-A) ≥ 1.0g/L

Exclusion Criteria

Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
Pregnancy or potential pregnancy
Under treatment of high-dose progestin therapy more than 1 months in recent 6 months
Confirmed diagnosis of any cancer in reproductive system
Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
Hypersensitivity or contradiction for using MA or atorvastatin
Already diagnosed with hyperlipidemia and using lipid-lowering drugs
With other factors of reproductive dysfunction
Strong request for uterine removal or other conservative treatment
Smoker (>15 cigarettes a day)
Drinker (>20 grams a day)
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