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Anti-diabetic drug
Metformin for Preventing Oral Cancer
Phase 2
Waitlist Available
Led By Scott M Lippman
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status >= 70%
Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia, or hyperplasia not associated with mechanical factors such as ill-fitted dentures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 weeks
Awards & highlights
Study Summary
This trial looks at whether metformin hydrochloride can help prevent oral cancer in patients with an oral premalignant lesion.
Who is the study for?
This trial is for people with certain mouth lesions that could turn into cancer, specifically oral leukoplakia or erythroplakia. Participants should have a life expectancy over 3 months, be able to take pills, and not have diabetes treated with insulin or other drugs. They must also agree to use birth control and not have had any recent treatments for other cancers.Check my eligibility
What is being tested?
The study is testing if Metformin Hydrochloride can prevent mouth cancer in patients with premalignant lesions. It's a phase IIa trial where the effects of the drug will be monitored through lab tests to see if it stops these lesions from becoming cancerous.See study design
What are the potential side effects?
Metformin may cause side effects like stomach upset, diarrhea, nausea and vomiting, muscle pain, breathing difficulties, low vitamin B12 levels, and possibly lactic acidosis which is rare but serious.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
Select...
I have oral leukoplakia or erythroplakia with changes in the tissue, not caused by dentures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Response to Metformin Intervention
Secondary outcome measures
Change in Measurements of Metformin Hydrochloride Concentrations in Serum and Saliva
Change in Serum Metabolic Markers
Change in Serum and Saliva Inflammatory and Angiogenic Cytokines
+4 moreOther outcome measures
Change in Saliva Microbiome Analyzed Using Flow Cytometry
Microbiome Signatures Correlated With Treatment Response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (extended-release metformin hydrochloride)Experimental Treatment2 Interventions
Patients receive extended-release metformin hydrochloride PO QD for 2 weeks and then BID for 10-12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1430
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,127 Total Patients Enrolled
8 Trials studying Oral Cancers
1,753 Patients Enrolled for Oral Cancers
Scott M LippmanPrincipal InvestigatorThe University of Arizona Medical Center-University Campus
1 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had head and neck cancer but was treated successfully over a year ago.I have diabetes and am taking insulin or pills for it.I have had allergic reactions to metformin or similar drugs, or I've used metformin in the last year.I have liver disease, hepatitis, cirrhosis, or portal hypertension.I've had cancer treatment in the last 2 years, but ongoing hormone therapy for breast cancer is okay.I am able to care for myself but may not be able to do active work.I can take pills by mouth.I have a history of kidney disease.I have oral leukoplakia or erythroplakia with changes in the tissue, not caused by dentures.I do not have any uncontrolled illnesses that could affect my participation.I have a non-invasive mouth cancer.I have had diabetic ketoacidosis in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (extended-release metformin hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Metformin Hydrochloride been cleared by the FDA?
"Metformin Hydrochloride, which is currently in Phase 2 clinical trials, received a safety score of 2. This suggests that while there is anecdotal evidence supporting its safety, none exists yet for its efficacy."
Answered by AI
Are researchers looking for new participants at this time?
"222 other clinical trials are currently enrolling patients that have oral leukoplakia while 180 studies are still admitting participants for Metformin Hydrochloride treatment."
Answered by AI
What similar research has been conducted using Metformin Hydrochloride?
"Metformin Hydrochloride was first trialled in 2002 by George Washington University. In the last two decades, there have been 1658 completed clinical trials and currently 180 active ones. A large portion of these ongoing studies are situated in San Diego, California."
Answered by AI
How many individuals are participating in this research?
"This particular trial is not looking for new participants at the moment. It was originally posted on June 10th, 2016 and updated September 20th, 2022. There are currently 222 trials actively recruiting patients with oral leukoplakia and 180 studies for Metformin Hydrochloride that are still enrolling."
Answered by AI
What medical conditions does Metformin Hydrochloride usually help to improve?
"Metformin Hydrochloride is most often used to treat exercise-induced conditions. However, it has also shown efficacy in treating other disorders such as type 1 diabetes mellitus and diabetic ketoacidosis."
Answered by AI
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