Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
Emory University
200 participants
Jan 9, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis
- Age equal to or above 18
Exclusion Criteria9
- Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction
- Tumor causing compression of the sella or pituitary dysfunction
- Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia
- Taking immunosuppressive drugs - including but not limited to methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeks of recent daily corticosteroid use or the use of corticosteroids equivalent to \> 85 mg of dexamethasone in the last month
- Current lymphoma or leukemia
- History of solid organ transplant
- Minors \< 18
- Pregnant women
- History of cerebrovascular accident leading to neurologic deficit
Interventions
Undergo blood sample collection
Undergo CT scan
Given dexamethasone or IV
Undergo MRI
Ancillary studies
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06132685