Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers (NCT03109847) | Clinical Trial Compass
TerminatedPhase 2
Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers
Stopped: Poor accrual
United States13 participantsStarted 2017-01-05
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 l…
What they're measuring
1
Change in Red Blood Cell Count From Pre-Resection to Post-Resection
Timeframe: Up to 36 months of study duration, an average of 1.5 months
2
Serum and Salivary Exosome Profile
Timeframe: Up to 36 months of study duration
3
Number of Adverse Events
Timeframe: Up to 36 months of study duration, an average of 1.5 months
Trial details
NCT IDNCT03109847
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University