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
NCT ID: NCT01877564
Last Updated: 2017-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2013-08-29
2017-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 - Metformin
oral metformin at 500 mg twice a day for 14-21 days followed by surgery
Metformin
Group 2 - No treatment
No interventions assigned to this group
Interventions
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Metformin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
65 Years
FEMALE
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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138647
Identifier Type: -
Identifier Source: org_study_id