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

September 25, 2017 updated by: University of Arkansas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - Metformin
oral metformin at 500 mg twice a day for 14-21 days followed by surgery
Drug: Metformin
No Intervention: Group 2 - No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IHC-based Tissue Markers of Proliferation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2013

Primary Completion (Actual)

August 10, 2016

Study Completion (Actual)

July 10, 2017

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 138647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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