Phase 2
N=10
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
Adenocarcinoma of the Endometrium
Bottom Line
View on ClinicalTrials.gov: NCT01877564 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: IHC-based Tissue Markers of Proliferation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IHC-based Tissue Markers of Proliferation |
— | — |
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.
Eligibility Criteria
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT01877564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.