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

Description

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.

Conditions

Low Grade Glioma, Malignant Brain Glioma, Malignant Brain Neoplasm, Meningioma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Low Grade Glioma
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Kimberly Hoang, MD, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

2028-07-30