Adenocarcinoma of the Endometrium Clinical Trial
Official title:
A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women
| Verified date | September 2017 |
| Source | University of Arkansas |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 10, 2017 |
| Est. primary completion date | August 10, 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium - Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2 - Candidate for surgical removal of their uterus as part of their endometrial cancer treatment - Subjects must have signed informed consent - Age 42 - 65 years of age - Electrocorticogram (ECOG) Performance status of 0 - 2 - History of adequate renal, liver, and bone marrow function: - Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range) - Platelets: (180K/cmm) - Liver Function Test(LFTs): Normal bilirubin (<2.0mg/dL), AST/ALT (2xULN) - Renal function: creatinine less than 1.4 - Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months. Exclusion Criteria: - Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma - History of diabetes mellitus Type 1 or Type 2. - Receiving metformin prior to enrollment - Known hypersensitivity to metformin. - Unable to swallow and retain oral medication. - Pregnant or lactating. - Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years - If the physician feels that the candidate is not suitable for the study, he/she will be excluded. - Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation. - Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation. - History of lactic or other metabolic acidosis. - Uncontrolled infectious disease. - History of positivity for human immunodeficiency virus (HIV). - History of congestive heart failure requiring pharmacologic treatment. - History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily. - Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel. - Current use of medications for weight loss. - Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| University of Arkansas |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IHC-based Tissue Markers of Proliferation | 1 year |