Clinical trial · Interventional
Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
| Malignant Brain Glioma | Malignant Brain Glioma | ONTOLOGY_EXACT | 0.98 |
| Malignant Brain Neoplasm | Malignant Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (NDS)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Drug: Dexamethasone
- Procedure: Magnetic Resonance Imaging
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (RDS)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available