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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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

Qualifiers

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

Age equal to or above 18

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Dexamethasone
  • Magnetic Resonance Imaging
  • Questionnaire Administration

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator