Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial

Meningioma Clinical Trial

Official title: Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)

Status Not yet recruiting

Clinical Trial Summary

This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. The primary objective of this study is to evaluate the efficacy of a reduced dosage steroid schedule (RDS) in patients who have undergone craniotomy for high grade glioma (HGG), low grade glioma (LGG), brain metastasis (BM), and meningiomas as compared with the normal dosing schedule (NDS).

II. RDS after undergoing craniotomy for brain tumor has no impact on length of stay, 30 day readmission, and need for repeat imaging when compared to NDS.

SECONDARY OBJECTIVE:

I. RDS after craniotomy for brain tumor has no impact on development of steroid related side effects (new onset or worsening hypertension, hyperglycemia, wound infection, impaired wound healing, steroid dependence, neuropsychiatric disturbance) when compared to NDS.

TERTIARY/EXPLORATORY OBJECTIVE:

I. RDS after craniotomy has no effect on lymphocyte count and differential at 10-14 days after surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (NDS): Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan during inpatient stay as part of standard of care.

ARM II (RDS): Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone intravenously (IV) and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma
• Low Grade Glioma
• Malignant Brain Glioma
• Malignant Brain Neoplasm
• Meningioma

• NCT number: NCT06132685
• Study type: Interventional
• Source: Emory University
• Contact: Kimberly Hoang, MD
• Phone: 404-778-5770
• Email: kbhoang@emory.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Completion date: July 30, 2028