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Back|NCT06132685Recruiting
Official Title

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

Phase
Phase 2
Sponsor
Emory University
Enrollment
200
Timeline
Jan 2025 → Jul 2028
About This Study

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 Criteria

Inclusion Criteria

  • 1Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis
  • 2Age equal to or above 18

Exclusion Criteria

  • 1Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction
  • 2Tumor causing compression of the sella or pituitary dysfunction
  • 3Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia
  • 4Taking 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
  • 5Current lymphoma or leukemia
  • 6History of solid organ transplant
  • 7Minors \< 18
  • 8Pregnant women
  • 9History of cerebrovascular accident leading to neurologic deficit

Locations

1 site participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Agnes Harutyunyan

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →