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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Endometrium Drug: Metformin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 29, 2013
Actual Primary Completion Date : August 10, 2016
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. IHC-based Tissue Markers of Proliferation [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 (<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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877564


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Study Protocol  [PDF] May 24, 2016
Statistical Analysis Plan  [PDF] May 24, 2016

More Information
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01877564    
Other Study ID Numbers: 138647
First Posted: June 13, 2013    Key Record Dates
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Adenocarcinoma
Uterine Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
 Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs