Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
NCT ID: NCT06132685
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-01-09
2028-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age equal to or above 18
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Kimberly Bojanowski Hoang
Principal Investigator
Principal Investigators
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Kimberly Hoang, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-04702
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00003975
Identifier Type: OTHER
Identifier Source: secondary_id
WINSHIP5678-22
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00003975
Identifier Type: -
Identifier Source: org_study_id
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