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

Last updated: February 6, 2026
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

2

Condition

Brain Cancer

Brain Tumor

Neurofibromatosis

Treatment

Questionnaire Administration

Biospecimen Collection

Dexamethasone

Clinical Study ID

NCT06132685
STUDY00003975
P30CA138292
WINSHIP5678-22
NCI-2023-04702
STUDY00003975
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with radiographic findings consistent with either HGG, LGG, Meningioma, orbrain metastasis

  • Age equal to or above 18

Exclusion

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 combinedimmunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia

  • Taking immunosuppressive drugs - including but not limited to methotrexate,mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeksof recent daily corticosteroid use or the use of corticosteroids equivalent to > 85mg 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

Study Design

Total Participants: 200
Treatment Group(s): 5
Primary Treatment: Questionnaire Administration
Phase: 2
Study Start date:
January 09, 2025
Estimated Completion Date:
July 30, 2028

Study 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 onset or worsening hypertension, hyperglycemia, wound infection, impaired wound healing, steroid dependence, neuropsychiatric disturbance) when compared to NDS.

TERTIARY/EXPLORATORY OBJECTIVE:

I. RDS after craniotomy has no effect on lymphocyte count and differential at 10-14 days after surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (NDS): Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan during inpatient stay as part of standard of care.

ARM II (RDS): Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone intravenously (IV) and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.

Connect with a study center

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University Hospital/Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

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