Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
Emory University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis * Age equal to or above 18 Exclusion Criteria: * 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. Great…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- DrugDexamethasone
Given dexamethasone or IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherQuestionnaire Administration
Ancillary studies
Location
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia