Metformin Hydrochloride in Mitigating Side Effects of Radioactive Iodine Treatment in Patients With Differentiated Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT03109847|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thyroid||Drug: Metformin Hydrochloride Other: Radioactive Iodine Other: Placebo||Phase 2|
I. To determine 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.
I. Assess safety and tolerability of metformin treatment in subjects undergoing RAI treatment for differentiated thyroid cancer.
II. To determine 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study of Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Well-Differentiated Thyroid Cancers|
|Actual Study Start Date :||January 5, 2017|
|Estimated Primary Completion Date :||June 8, 2021|
|Estimated Study Completion Date :||January 2022|
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.
Drug: Metformin Hydrochloride
Other Names:Other: Radioactive Iodine
Undergo 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
Other: Radioactive Iodine
Undergo radioactive iodine treatmentOther: Placebo
- Complete blood count [ Time Frame: Up to 36 months of study duration ]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.
- Serum and salivary exosome profile [ Time Frame: Up to 36 months of study duration ]Will be modeled using mixed effects linear regression
- Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 36 months of study duration ]
- Xerostomia assessed by modified Vanderbilt Head and Neck Cancer Symposium Survey (version 2.0) [ Time Frame: Up to 36 months of study duration ]
- Xerophthalmia assessed by modified Vanderbilt Head and Neck Cancer Symposium Survey (version 2.0) [ Time Frame: Up to 36 months of study duration ]
- Dysgeusia assessed by modified Vanderbilt Head and Neck Cancer Symposium Survey (version 2.0) [ Time Frame: Up to 36 months of study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109847
|Contact: Joseph Curry, MD||(215) 955-6760|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Joseph Curry, MD 215-955-6760|
|Principal Investigator:||Joseph Curry, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|