To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Statins 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 with endometrial cancer who met the inclusion criteria were randomly divided into the control group and the experimental group in a 1:1 ratio according to the random numbers generated in advance. The administration regimen for the two groups was as follows: 1. Control group: progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa 3.75mg subcutaneous injection monthly); 2. Trial group: progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; or rosuvastatin 5mg/ day; or pivastatin 2mg/ day); The specific selection of progesterone regimen was based on whether the patients had oral progesterone contraindications and if BMI≥28kg/m2 was not suitable for oral progesterone, Mirena +GnRHa regimen was selected. The choice of statin drugs is based on the results of the drug sensitivity test of the patient's tumor tissue, and the most sensitive one of the three drugs is selected. 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. 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
38
Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGPathological cumulative complete response rate;
From 6 to 7 months: From date of initial therapy until the date of CR.
Time frame: assessed up to 7 months
Pathological cumulative complete response rate;
From 3 to 4 months; From date of initial therapy until the date of CR.
Time frame: assessed up to 4 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 7 months
Overall complete response rate
Pathological response duration
Time frame: up to 2 years
Relapse rate
Relapse 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.
Pregnancy rate
Number of pregnancies after complete remission.
Time frame: up to 15 months after the end of treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.