drugset / Trial / NCT06484166

Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .

NCT06484166 ↗

Completed 132 enrolled West China Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Radiotherapy always results in many complications such as radiation dermatitis, dry mouth, cranial nerve damage, and swallowing function. Among them, radiation dermatitis is confirmed to occur in the majority of tumor patients receiving radiotherapy, which not only affects the appearance but also causes the interruption of radiotherapy in severe cases. At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards. This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.

Timeline

Start
2024-08-01
Primary completion
2025-03-01
Completion
2025-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trolamine Unknown — Topical

Indications