Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers

NCT03109847 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 16D.564JT 9411
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how will metformin hydrochloride works in mitigating the side effects of radioactive iodine treatment in patients with differentiated thyroid cancer. Metformin hydrochloride may reduce the metabolic activity of cancer cell and of surrounding supportive tissues.

Conditions

Thyroid

Outcome Measures

Primary Outcomes (3)

• Change in Red Blood Cell Count From Pre-Resection to Post-Resection

  Change in red blood cell count measured from baseline to two weeks after completion of RAI, measured via standard CBC laboratory testing. Longitudinal measures of CBC will be modeled using mixed effects linear regression. Will use a linear contrast to test the null hypothesis that change from pre-resection to post-resection is the same in the control and metformin groups.

  Up to 36 months of study duration, an average of 1.5 months

• Serum and Salivary Exosome Profile

  Will be modeled using mixed effects linear regression

  Up to 36 months of study duration

• Number of Adverse Events

  Number of adverse events assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version v 4.0, from treatment initiation through 15 days post-treatment follow-up.

  Up to 36 months of study duration, an average of 1.5 months

Secondary Outcomes (3)

• Xerostomia Assessed by Modified Vanderbilt Head and Neck Cancer Symposium Survey (Version 2.0)

  Up to 36 months of study duration

• Xerophthalmia Assessed by Modified Vanderbilt Head and Neck Cancer Symposium Survey (Version 2.0)

  Up to 36 months of study duration

• Dysgeusia Assessed by Modified Vanderbilt Head and Neck Cancer Symposium Survey (Version 2.0)

  Up to 36 months of study duration

Study Arms (2)

Arm I (metformin hydrochloride)

EXPERIMENTAL

Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.

Drug: Metformin Hydrochloride; Other: Radioactive Iodine

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment

Other: Radioactive Iodine; Other: Placebo

Interventions

Radioactive Iodine OTHER

Undergo radioactive iodine treatment

Arm I (metformin hydrochloride); Arm II (placebo)

Placebo OTHER

Given orally

Arm II (placebo)

Metformin Hydrochloride DRUG

Given Orally

Also known as: 1,1-Dimethylbiguanide Hydrochloride, 1115-70-4, 91485, Cidophage, Dimefor, Glucoformin, Metformin HCl

Arm I (metformin hydrochloride)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a diagnosis of differentiated thyroid cancer who have undergone total or near-total thyroidectomy and are candidates for iodine I-131 (I-131) treatment at Thomas Jefferson University Hospital (TJUH) are eligible to participate
• Subjects must be diagnosed with differentiated thyroid cancer
• Patients must have previously undergone or plan to undergo thyroidectomy; for those patients who have previously undergone surgery, pre-operative labs, including complete blood cell count with differential must be available
• Patients who have a negative urine pregnancy test prior to enrollment. This should be done as part of pre-admission testing prior to surgery (within 14 days of study enrollment).
• All subjects must be able to comprehend and sign a written informed consent document

You may not qualify if:

• Subjects who are pregnant or may become pregnant during metformin administration in accordance with radioactive iodine treatment guidelines
• Subjects on metformin for any reason during the preceding 4 weeks
• Diabetic subjects are eligible if they are not taking metformin, insulin or sulfonylureas
• Subjects who have received iodinated contrast dye. Metformin treatment can be started the day after subjects complete iodinated contrast treatment. If a CT scan with contrast is scheduled after screening and consent, the metformin treatment should be stopped the day before iodinated contrast administration. Metformin can be resumed on the day after last iodinated contrast was administered to the subject.
• Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests (previously documented alanine aminotransferase greater than 40 IU/dL and/or plasma aspartate aminotransferase greater than 45 IU/d); patients who have a history of hepatic dysfunction or hepatic disease but whose most recent liver function tests have been documented as normal will be eligible to participate
• Patients with plasma creatinine level greater than 1.3 mg/dL
• Patients with plasma alkaline phosphatase greater than 190 IU/dL
• Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
• Patients with history of congestive heart failure
• Patients with myocardial ischemia or peripheral muscle ischemia
• Patients with sepsis or severe infection
• Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment
• Patients with a current history (in the past 30 days) of heavy drinking which is defined in accordance with CDC definition as more than 8 drinks per week for women and more than 15 drinks per week for men. A standard drink contains .6 ounces of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey). While on study, patients should limit their alcohol consumption to no more than 8 drinks per week for women and no more than 15 drinks per week for men. Patients who feel they cannot comply with this recommendation are not eligible.
• Patients with a systemic disease that could affect their bone marrow or peripheral blood cells (e.g. systemic lupus erythematosus, human immunodeficiency virus infection, rheumatoid arthritis)
• Patients who have received or will receive medication that could affect their hematologic state (tyrosine kinase inhibitors, cytotoxic chemotherapy)

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Metformin

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Joseph Curry, MD
• Organization: Thomas Jefferson University

joseph.curry@jefferson.edu

215-503-6828

Study Officials

• Joseph Curry, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 12, 2017
• Study Start: January 5, 2017
• Primary Completion: December 29, 2020
• Study Completion: December 7, 2022
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Locations

US (1)