NCT03480971 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ahmed LA, Shehata NI, Abdelkader NF, Khattab MM
Tempol, a superoxide dismutase mimetic agent, ameliorates cisplatin-induced nephrotoxicity through alleviation of mitochondrial dysfunction in mice. PLoS One. 2014 Oct 1;9(10):e108889. doi: 10.1371/journal.pone.0108889. eCollection 2014. Erratum in: PLoS One. 2014;9(12):e115983.
Arany I, Safirstein RL
Cisplatin nephrotoxicity. Semin Nephrol. 2003 Sep;23(5):460-4. Review.
Hartmann JT, Lipp HP
Toxicity of platinum compounds. Expert Opin Pharmacother. 2003 Jun;4(6):889-901. Review.
Mitchell JB, Anver MR, Sowers AL, Rosenberg PS, Figueroa M, Thetford A, Krishna MC, Albert PS, Cook JA
The antioxidant tempol reduces carcinogenesis and enhances survival in mice when administered after nonlethal total body radiation. Cancer Res. 2012 Sep 15;72(18):4846-55. doi: 10.1158/0008-5472.CAN-12-1879. Epub 2012 Jul 17.
Samuni A, Krishna CM, Mitchell JB, Collins CR, Russo A
Superoxide reaction with nitroxides. Free Radic Res Commun. 1990;9(3-6):241-9.
Samuni A, Mitchell JB, DeGraff W, Krishna CM, Samuni U, Russo A
Nitroxide SOD-mimics: modes of action. Free Radic Res Commun. 1991;12-13 Pt 1:187-94.
Samuni A, Winkelsberg D, Pinson A, Hahn SM, Mitchell JB, Russo A
Nitroxide stable radicals protect beating cardiomyocytes against oxidative damage. J Clin Invest. 1991 May;87(5):1526-30.
Sastry J, Kellie SJ
Severe neurotoxicity, ototoxicity and nephrotoxicity following high-dose cisplatin and amifostine. Pediatr Hematol Oncol. 2005 Jul-Aug;22(5):441-5.
Scully C, Sonis S, Diz PD
Oral mucositis. Oral Dis. 2006 May;12(3):229-41. Review.

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

Details for clinical trial NCT03480971

Clinical trial NCT03480971 - References