Clinical trial NCT05675787: Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Official title: Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atypical Endometrial Hyperplasia
Endometrial Carcinoma Stage I
Keywords: Endometrial Carcinoma
Atypical Endometrial Hyperplasia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 82
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;
* 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

Exclusion Criteria:

* Hypersensitivity or contradiction for using MPA or atorvastatin
* Pregnancy or potential pregnancy
* Confirmed diagnosis of any cancer in reproductive system
* Already diagnosed with hyperlipidemia and using lipid-lowering drugs
* Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* 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)

Primary outcomes:
measure: Pathological cumulative complete response rate;
timeFrame: assessed up to 4 months
Secondary outcomes:
measure: Pathological cumulative complete response rate;
timeFrame: assessed up to 8 months
measure: The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
timeFrame: assessed up to 4 months
measure: Overall complete response rate
timeFrame: up to 2 years
measure: Pathological response rate classified by different blood lipid level
timeFrame: up to 2 years;
measure: Relapse rate
timeFrame: up to 15 months after the end of treatment
measure: Pregnancy rate
timeFrame: up to 15 months after the end of treatment
measure: Toxic Side Effect
timeFrame: up to 3 months after the end of treatment
Other outcomes:
Locations:
city: Peking
country: China
facility: Wang Jianliu
state: Beijing
Study officials:
References: