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Trial Title:
Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
NCT ID:
NCT06102863
Condition:
Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I
Conditions: Official terms:
Carcinoma
Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Atorvastatin
Rosuvastatin Calcium
Calcium
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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 (no preset position, no specific object).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Description:
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);
Arm group label:
experimental group
Summary:
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.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The pathological types are consistent with:
1. Atypical endometrial hyperplasia;
2. Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and
pelvic and abdominal MRI before treatment excluded deep muscle infiltration,
cervical involvement, and extrauterine metastasis;
3. There is a strong need to preserve reproductive function; Age ≤45 years old;
4. Progesterone resistant patients predicted by the progesterone sensitivity
prediction model (NCT05647109) established by our team in the previous study of
endometrial cancer were prospectively randomized; The predicted progesterone
sensitive patients were prospectively observed;
5. Informed consent and signed informed consent;
6. have follow-up conditions and are willing to continue to follow the visitors in
the hospital;
7. Patients with normal/abnormal blood lipids who have not taken any
lipid-lowering drugs;
8. A. Newly treated patients: did not use any nursery therapy drugs (progesterone,
GNRH-a); B. 1 course of treatment (12 weeks) the lesions persisted; C. Partial
remission for 2 courses of treatment (24 weeks);
Exclusion Criteria:
- (1) Patients with severe internal diseases and severe impairment of liver and kidney
function;
(2) Disease progression, extrauterine metastasis (cervical invasion or distant
metastasis such as pelvic cavity) during treatment;
(3) People with therapeutic drug allergies and contraindications;
(4) 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 use progesterone;
(5) Patients with deep vein thrombosis, stroke and myocardial infarction during
treatment;
(6) Alcoholics (> 20g/ day);
(7) Smokers (> 15 cigarettes/day)
Gender:
Female
Minimum age:
17 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianliu Wang
Phone:
wangjianliu1203@163.com
Email:
wangjianliu1203@163.com
Investigator:
Last name:
HE YIJIAO, PHD/MD
Email:
Sub-Investigator
Start date:
April 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Beihang University
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102863
