An Endometrial Cancer Chemoprevention Study of Metformin
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01697566
First received: September 28, 2012
Last updated: January 26, 2015
Last verified: January 2015
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Purpose
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. It is often referred to as "pre-diabetes". Many people with insulin resistance have high levels of both sugar and insulin in their blood at the same time, which have been reported in patients with endometrial cancer.
In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Lifestyle intervention is made up of a series of in-person sessions where you meet with a coach to discuss strategies for losing weight and ways to increase physical activity. It also consists of materials designed to help you lose weight and will offer opportunities for supervised exercise.
| Condition | Intervention | Phase |
|---|---|---|
|
Gynecology |
Drug: Metformin Other: Placebo Procedure: Endometrial Biopsy Behavioral: Lifestyle Intervention Behavioral: Questionnaires |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An Endometrial Cancer Chemoprevention Study of Metformin Versus No Treatment in Women With a Body Mass Index (BMI) >/= 35 kg.m2 and Hyperinsulinemia |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Effect of Metformin and/or Lifestyle Intervention on Biomarkers. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Differences in Ki-67 and other biomarkers analyzed using a 2x2 ANOVA. Other biomarkers examined include a) a panel of genes relevant to estrogen dependent endometrial proliferation, hyperplasia and cancer using Q-PCR, b) biomarkers specific to the effect of metformin treatment (phospho-AMPKa, phospho-ACC, phospho-mTOR and phospho-S6 ribosomal protein and c) potential biomarkers of modulation of insulin sensitivity on the human endometrial proteome using reverse phase protein arrays (RPPA).
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2013 |
| Estimated Primary Completion Date: | May 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin
850 mg by mouth twice a day for four, 30 day cycles.
|
Drug: Metformin
850 mg by mouth twice a day for four, 30 day cycles.
Procedure: Endometrial Biopsy
Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
|
Experimental: Placebo + Lifestyle Intervention
Placebo taken by mouth twice daily for 4, 30 day cycles. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
|
Other: Placebo
Placebo taken by mouth twice daily for 4, 30 day cycles.
Other Name: sugar pill
Procedure: Endometrial Biopsy
Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Lifestyle Intervention
Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
|
Experimental: Metformin + Lifestyle Intervention
Metformin 850 mg by mouth twice a day for four, 30 day cycles. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
|
Drug: Metformin
850 mg by mouth twice a day for four, 30 day cycles.
Procedure: Endometrial Biopsy
Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Lifestyle Intervention
Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
|
Placebo Comparator: Placebo
Placebo taken by mouth twice daily for 4, 30 day cycles.
|
Other: Placebo
Placebo taken by mouth twice daily for 4, 30 day cycles.
Other Name: sugar pill
Procedure: Endometrial Biopsy
Endometrial biopsies obtained at baseline and after 4 months.
Behavioral: Questionnaires
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
Other Name: surveys
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
- Menopause as defined as no menses for 1 year and/or FSH >/= 25.8 mIU/ml
- Must be able to read, write, and speak English.
- Must have a Primary Care Provider (PCP).
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
- Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes.
- Known allergy to Metformin or other biguanide (Proguanil).
- Use of Aromatase Inhibitors, GNRH-agonists i.e.Lupron, Zoladex within the last 6 months
- Use of SERMS (selective estrogen receptor modulators) in the past 6 months, including Tamoxifen and Raloxifene
- Hormone replacement therapy within the last 6 months
- Women who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancer
- Patients who have had prior radiation to the pelvis
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697566
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697566
Contacts
| Contact: Karen H. Lu, MD | 713-745-8902 |
Locations
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Karen H. Lu, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01697566 History of Changes |
| Other Study ID Numbers: | 2011-0739, 5P50-CA098258, NCI-2013-00834 |
| Study First Received: | September 28, 2012 |
| Last Updated: | January 26, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
Gynecology Endometrial Cancer Chemoprevention Obese Body Mass Index (BMI) >/= 35 kg.m2 Post-menopausal Hyperinsulinemia |
Metformin Placebo Sugar pill Lifestyle intervention Diet Exercise |
Additional relevant MeSH terms:
|
Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 25, 2015