Restrictive Use of Dexamethasone in Glioblastoma

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Feb 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a limited amount of the steroid dexamethasone (DEX) in patients with glioblastoma, a type of brain cancer. DEX is usually given to help reduce swelling and pressure in the brain, but it can also cause serious side effects that might negatively impact a patient’s survival. The trial aims to find out if some patients can safely receive less DEX during their treatment without experiencing serious complications, such as worsening neurological symptoms or the need for additional surgery.

To participate in the trial, individuals must be between 18 and 90 years old and have a newly diagnosed brain lesion that doctors suspect might be glioblastoma, without significant swelling. They should also have a good level of consciousness and not have had steroid treatment for more than one day before joining the study. Participants will be monitored closely to ensure their safety and to understand how well this limited use of DEX works. This could potentially lead to better treatment options that minimize side effects for glioblastoma patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed supratentorial contrast enhancing lesion suspicious of glioblastoma without major mass effect, amenable to surgical resection
• • Age 18 - 90 years
• • Midline Shift ≤ 3mm
• • GCS ≥ 14
• • NIHSS ≤ 3
• • Provided written informed consent
• Exclusion Criteria:
• • Infratentorial lesions, brainstem lesions, multifocal lesions
• • Therapy with steroids for \>1 day before inclusion
• • Need for treatment with steroids due to any other disease
• • Contraindications to the administration of Dexamethasone
• • Pregnancy or breastfeeding