Investigator initiated registrational trial of Metformin for atypical endometrial hyperplasia and endometrial carcinoma

JRCT ID: jRCT2031190065

Registered date:30/07/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: atypical endometrial hyperplasia and endometrial carcinoma
• Date of first enrollment: 25/09/2019
• Target sample size: 138
• Study type: Interventional
• Intervention(s): Randomization to 3 group and administration of study drug (Metformin)

Outcome(s)

• Primary Outcome: The three-year disease-free survival rate

Secondary Outcome

Disease-free survival rate
The overall response rate to MPA therapy
Conception rate following treatment
The outcome of pregnancy
Toxicity evaluation
Changes in insulin resistance and body mass index (BMI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 42age old
• Gender: Female

Include criteria

1.Histologically confirmed AEH or well-defferentiated endometrioid adenocarcinoma, presumed to be International Federation of Gynecology and Obsterics IA, and in which the EC was limited to the endometrium. Endometrial tissue sampling for diagnosis was performed by dilatation and curettage.
2. No prior treatment with a high dose of progestin, the levonorgestrel-releasing intrauterine system, or chemotherapy for an endometrial lesion (the uses of low or medium doses of a progestin for menstrual cycle regulation were permitted).
3. Over 18 years of age and under 42 years of age
4. Eastern Cooperative Oncology Group Performance Status 0
5. Fulfillment of each of the following parameters
6. No prior medical history of chemical sensitivity to any of the chemicals being used in the trial (MPA and metformin)
7. No clinical problem on electrocardiography
8. The patient and legally acceptable representative provided written informed consent

Exclude criteria

1.Contraindication to the drugs used in this trial (MPA and metformin)
1.1.Susceptible to lactic acidosis
1.1.1.A history of lactic acidosis
1.1.2.Moderate to severe kidney damage or dialysis
1.1.3.Severe liver damage
1.1.4.Shock, cardiac arrest, cardiac infarction, thrombosis of the lung, or severe cardiovascular and/or lung damage
1.1.5.Ingestion of excessive amounts of alcohol
1.1.6.Gastrointestinal damage such as dehydration or diarrhea and/or vomiting that could cause dehydration
1.2.Serious ketosis, diabetic coma or pre-coma, or type I diabetes
1.3.Serious infections and/or injuries, a medical history including recent surgery, or the expectation that the patient will soon undergo surgery
1.4.Malnourishment or starvation, hyposthenia, or pituitary and/or adrenal gland disorders
1.5.Pregnancy or the expectation that the woman could be pregnant
1.6.Prior medical history of chemical sensitivity to biguanides or the compounds present in the drugs being tested
1.7.High risk of thrombosis
1.7.1.Surgery within the past week, cerebral and/or cardiac infarction, thrombophlebitis or a prior history thereof, valvular heart disease, atrial fibrillation, endocarditis, other serious cardiac conditions, or the current administration of hormone treatments
1.8.Undiagnosed breast lesions or vaginal and/or urinary bleeding
1.9.Serious liver damage
1.10.Hypocalcemia
2.Psychosis or mental symptoms that could make it difficult for patients to participate in the trial
3.Uncontrolled diabetes mellitus
4.Diabetic patients who already take biguanides, including metformin (patients who manage their diabetes via diet and exercise therapy, or those who take medicines apart from metformin are eligible).
5.Concomitant malignancies
6.Systemic administration of steroids
7.Determined to be ineligible by the physician in charge for any other reason

Related Information

• Primary Sponsor: Mitsuhashi Akira
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development