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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06132685
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Low Grade Glioma
  • Malignant Brain Glioma
  • Malignant Brain Neoplasm
  • Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Dexamethasone — DRUG
    Given dexamethasone or IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jan 9, 2025
Status verified
Jan 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Length of hospital stay [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Agnes Harutyunyan
[email protected]
Kimberly Hoang, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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