Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03109847
Phase
PHASE2
Status
Terminated

Conditions

  • Thyroid

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    Given Orally
  • Radioactive Iodine — OTHER
    Undergo radioactive iodine treatment
  • Placebo — OTHER
    Given orally

Study Details

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.

Key Dates

Start date
Jan 5, 2017
Status verified
Nov 2025
Primary completion
Dec 29, 2020
Completion
Dec 7, 2022

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (metformin hydrochloride)
    Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment

Primary Outcome Measure

Change in Red Blood Cell Count From Pre-Resection to Post-Resection [ Time Frame: Up to 36 months of study duration, an average of 1.5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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