Glioblastoma
Conditions
Interventions
This is a randomized, prospective pilot study (analogous to a phase II study for drugs). Designed to test the efficacy and safety of intranasal perillyl alcohol combined with standard treatment in pat
Sponsors
Hospital de Clínicas da Unicamp
Universidade Estadual de Campinas
Hospital Municipal Dr Mario Gatti
Universidade do Estado do Rio de Janeiro
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult individuals; of both genders and transgenders; aged 18 and over; diagnosed with Glioblastoma; who underwent a surgical procedure with partial removal of the tumor evidenced by brain MRI; who will be starting standard treatment with radiotherapy and chemotherapy and have a KPS = 60
Exclusion criteria
Exclusion criteria: Patients allergic to lemon; who have the presence of another primary tumor or proven metastasis; who have a concomitant life-threatening disease or a pathology that affects blood circulation and the coagulation system; pregnant women or those intending to become pregnant and those who do not accept to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that survival will be increased in participants in the intervention group, which will be calculated using the Kaplan-Meier method and the differences in the data will be assessed using the bilateral log-rank test | — |
Secondary
| Measure | Time frame |
|---|---|
| The toxicity of radiotherapy and chemotherapy treatment associated with the use of perillyl alcohol will be assessed according to the criteria established in version 5.0 of the National Cancer Institute (NCI) Common Terminology Criteria. This protocol includes the identification, description and classification of adverse events, taking into account their severity and frequency | — |
Countries
Brazil
Contacts
Public ContactDaniela de Lima
Universidade Estadual de Campinas
Outcome results
None listed