Study of Tempol to Reduce Severe Mucositis and Other Side Effects in Adults with Head and Neck Cancer Undergoing Chemotherapy and Radiation

What this Trial Is About

Researchers are studying the use of Tempol to prevent or reduce side effects caused by cisplatin chemotherapy and radiation treatment in patients with head and neck cancer. The trial focuses on toxicities such as mucositis, nephrotoxicity, and ototoxicity, which commonly affect patients undergoing these treatments. This Phase 2 study involves 120 participants and aims to improve quality of life and treatment continuity by addressing these complications. Participants will be randomly assigned to receive either 1000 mg of Tempol oral solution or a placebo daily during their radiation therapy, which lasts about 6 to 8 weeks. Tempol is a compound that protects healthy cells without shielding cancer cells from treatment damage. Both groups will be monitored for the development and severity of mucositis, kidney damage, and hearing loss throughout the 10-week study period. During the study, participants will undergo regular assessments to track mucositis, kidney function, and hearing ability. Researchers will evaluate the safety, pharmacokinetics, and effectiveness of Tempol in reducing severe mucositis and other toxicities. Follow-up will include monitoring for adverse effects and overall health status. The trial lasts approximately 10 weeks, covering the treatment and observation periods.

Treatment of Radiation and Cisplatin Induced Toxicities with Tempol