Recruiting
Phase 2

Dexamethasone

Sponsor:

Emory University

Code:

NCT06132685

Conditions

Low Grade Glioma

Malignant Brain Glioma

Malignant Brain Neoplasm

Meningioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Dexamethasone

Magnetic Resonance Imaging

Questionnaire Administration

Study Details

Brief 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.

Conditions

Low Grade Glioma

Malignant Brain Glioma

Malignant Brain Neoplasm

Meningioma

Study ID

NCT06132685

Start date

Jan 9, 2025

Status verified date

Jan, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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. 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 MRI and CT scan during inpatient stay as part of standard of care.

experimental: Arm II (RDS)

Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone 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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT scan

Dexamethasone

Given dexamethasone or IV

Magnetic Resonance Imaging

Undergo MRI

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Length of hospital stay [ Time Frame: Up to 3 months ]
  • 30-day repeat admission rate [ Time Frame: At 30 days after surgery ]
  • Need for repeat head imaging [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Kimberly Hoang, MD

404-778-5770kbhoang@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Agnes Harutyunyan

aharuty@emory.edu

Principal Investigator:

Kimberly Hoang, MD

More Information

Sponsor

Emory University

Last update posted

Feb 10, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-10.