Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy
Matrix Biomed, Inc.
120 participants
May 13, 2019
INTERVENTIONAL
Conditions
Summary
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Investigational product is Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) oral solution. Tempol solution is an orange-colored, aqueous solution containing 7% Tempol along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils.
The placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT03480971