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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

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ClinicalTrials.gov Identifier: NCT01877564
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE June 11, 2013
First Posted Date  ICMJE June 13, 2013
Results First Submitted Date  ICMJE August 9, 2017
Results First Posted Date  ICMJE October 25, 2017
Last Update Posted Date October 25, 2017
Actual Study Start Date  ICMJE August 29, 2013
Actual Primary Completion Date August 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
IHC-based Tissue Markers of Proliferation [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
Metformin-related adverse events. [ Time Frame: 06/2014 ]
Change History Complete list of historical versions of study NCT01877564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of the Endometrium
Intervention  ICMJE Drug: Metformin
Study Arms  ICMJE
  • Experimental: Group 1 - Metformin
    oral metformin at 500 mg twice a day for 14-21 days followed by surgery
    Intervention: Drug: Metformin
  • No Intervention: Group 2 - No treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2013)
40
Actual Study Completion Date  ICMJE July 10, 2017
Actual Primary Completion Date August 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01877564
Other Study ID Numbers  ICMJE 138647
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Arkansas
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP