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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis

• Age equal to or above 18

Locations
United States
Georgia
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Contact Information
Primary
Kimberly Hoang, MD
kbhoang@emory.edu
404-778-5770
Time Frame
Start Date: 2025-01-09
Estimated Completion Date: 2028-07-30
Participants
Target number of participants: 200
Treatments
Experimental: 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 MRI and CT scan during inpatient stay as part of standard of care.
Experimental: Arm II (RDS)
Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone 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.
Sponsors
Leads: Emory University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov