Adenocarcinoma of the Endometrium
Conditions
Brief summary
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.
Interventions
DRUGMetformin
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IHC-based Tissue Markers of Proliferation | 1 year |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the UAMS Gynecologic Oncology Clinic between August 2013 and July 2016.
Pre-assignment details
Subject eligibility was established before treatment randomization and included eligibility assessments, study assessments, lab tests, and pathology assessments.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Metformin oral metformin at 500 mg twice a day for 14-21 days followed by surgery
Metformin | 6 |
| Group 2 - No Treatment no metformin for 14-21 days | 4 |
| Total | 10 |
Baseline characteristics
| Characteristic | Group 2 - No Treatment | Total | Group 1 - Metformin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Continuous | 61 years | 60.8 years | 60.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 1 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 4 |
Outcome results
Primary
IHC-based Tissue Markers of Proliferation
Time frame: 1 year
Population: data were not collected