NCT03109847

Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers

Pilot Study of Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Well-Differentiated Thyroid Cancers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate if treatment with metformin hydrochloride (metformin) inhibits radioactive iodine (RAI)-induced myelosuppression and induces faster recovery of white blood cell count to baseline values, the blood counts will be compared in the pre- and post-treatment samples. SECONDARY OBJECTIVES: I. Assess safety and tolerability of metformin treatment in subjects undergoing RAI treatment for differentiated thyroid cancer. II. To assess the effect of metformin treatment on symptoms of xerostomia, xerophthalmia and dysgeusia as assessed by the Xerostomia Questionnaire (XQ), the modified Vanderbilt Head and Neck Cancer Symposium Survey (version 2.0), University of Washington Quality of Life Questionnaire, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ)-Head and Neck (H\&N)35.

Conditions

• Thyroid

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride	Given Orally
OTHER	Radioactive Iodine	Undergo radioactive iodine treatment
OTHER	Placebo	Given orally

Timeline

• Start date: 2017-01-05
• Primary completion: 2020-12-29
• Completion: 2022-12-07
• First posted: 2017-04-12
• Last updated: 2025-12-11
• Results posted: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study