Protocol for a pilot-randomized trial in newly diagnosed glioblastoma: standard care with or without daily intranasal...

Glioblastoma (GB) is a highly malignant brain tumor with poor prognosis and limited treatment options. Standard treatment, surgery followed by chemoradiation with temozolomide (TMZ), yields an average survival of 18 months. Preclinical studies indicate that perillyl alcohol (POH) is cytotoxic to TMZ-sensitive and -resistant cells and acts as a radiosensitizer. Clinical studies of intranasal POH show low toxicity and potential survival benefits in recurrent gliomas. This study aims to evaluate the effects of POH alongside standard treatment in newly diagnosed GB patients. Eligible patients at the Oncology Services of the University of Campinas General Hospital and Municipal Hospital Mário Gatti will be assigned to a control group (chemoradiation) or an intervention group (chemoradiation + POH). Follow-up will occur every 4 months for 1 year. The primary outcome is progression-free survival, with secondary outcomes including overall survival, blood levels of P-selectin and von Willebrand factor, and tumor response assessed by cranial MRI. Previous studies have reported positive effects of intranasal POH in patients with recurrent gliomas. This study evaluates an adjunct protocol combining intranasal POH with standard therapy in newly diagnosed GB patients. This randomized clinical trial aims to support future research and guide clinical practice.Clinical trial registration: RBR-4ngc9n5 (www.ensaiosclinicos.gov.br).