To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue was detected by Raman scattering instrument. And Age, height, weight, waistline, blood pressure, basic history of infertility and family cancer will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 770. Patients will receive MPA (Medroxyprogesterone acetate) 250-500 mg by mouth daily plus atorvastatin 20mg by mouth daily for at least 3 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. Patients with PD will be recommended for hysterectomy. For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Three months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
Wang Jianliu
Beijing, Beijing Municipality, China
RECRUITINGPathological cumulative complete response rate;
3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,
Time frame: assessed up to 4 months
Pathological cumulative complete response rate;
From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy,
Time frame: assessed up to 8 months
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion
Time frame: assessed up to 4 months
Overall complete response rate
Pathological response duration
Time frame: up to 2 years
Pathological response rate classified by different blood lipid level
Pathological response rate classified by different blood lipid level
Time frame: up to 2 years;
Relapse rate
Relapse rate
Time frame: up to 15 months after the end of treatment
Pregnancy rate
Pregnancy rate
Time frame: up to 15 months after the end of treatment
Toxic Side Effect
Toxicity evaluation according to CTCAE 5.0 version.
Time frame: up to 3 months after the end of treatment
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