An Endometrial Cancer Chemoprevention Study of Metformin

What this trial studies

The goal of this clinical research study is to learn about the effects of metformin and/or a program called "lifestyle intervention" on the endometrium (inner lining of the uterus) in post-menopausal women who are also obese (both are risk factors for endometrial cancer). Researchers also want to learn how insulin levels will be affected by metformin, diet and/or exercise. Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a condition in which the body makes insulin but does not use it properly.

Conditions in scope

• Gynecology

Interventions

• Metformin (Drug) — Participants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times…
• Placebo (Other) — Placebo taken by mouth twice daily for 4, 30 day cycles.
• Endometrial Biopsy (Procedure) — Endometrial biopsies obtained at baseline and after 4 months.
• Lifestyle Intervention (Behavioral) — Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
• Questionnaires (Behavioral) — Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.

Who can join

Women only · Ages 50 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• For this study, only women will be enrolled.
• Body Mass Index (BMI) \> or = 30 kg/m2
• Not frankly diabetic, as measured by a fasting blood glucose \</=126 mg/dL.
• Demonstrate hyperinsulinemia with a QUICK I value \</= 0.357.
• Age \>/= 50 and \</= 65
• Zubrod Performance Scale 0-1
• Hemoglobin \>/= 10 g/dl
• TSH 0.27 - 4.20 µlU/mL

Exclusion criteria

• Prior hysterectomy or endometrial ablation
• ALT \>/r = 2.0x Upper Limit of Normal (ULN)
• Serum creatinine \> /= 1.4 mg/dl
• Triglycerides (fasting) \>/ = 400
• Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
• Significant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior change.
• Participant reported history of congestive heart failure
• Prior treatment with Metformin

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2013-05-30
• Primary completion: 2024-05-30
• Last update posted: 2025-06-11
• First posted: 2012-10-02

Sponsor & contact

Lead sponsor: M.D. Anderson Cancer Center (Other)

Collaborators: National Cancer Institute (NCI)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• To Evaluate the Participant Body Weight in Pounds (Lbs) (Visit 2 (1 week), 4 months, and 1 year)
  This study will use a 2 x 2 randomized design with all 100 post- menopausal subjects being randomized to metformin, placebo, placebo and intensive lifestyle intervention, or metformin and intensive lifestyle intervention. Treatments will last 4 months. Participants will be assessed at baseline and end of treatment with endometrial sampling to see if there are changes in the biomarkers.
• To Evaluate the Percentage of Ki-67 Positive Cells (Visit 2 (1 week), 4 months, and 1 year)
  The Q-PCR analyses will be performed in the Quantitative Genomics Core Facility at the University of Texas Medical School at Houston. Over the last 3 years we have used several techniques including differential display, microchip array screening, and real-time quantitative PCR to find such genes. The tools we have developed are directly applicable to the investigation of surrogate endpoint biomarkers…

Related ClearedRx care

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