RecruitingPhase 2NCT06132685

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)


Sponsor

Emory University

Enrollment

200 participants

Start Date

Jan 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called the PODS Trial) studies the best way to reduce or taper the steroid medication dexamethasone after brain tumor surgery (craniotomy). Dexamethasone is commonly used to reduce brain swelling after surgery, but long-term use has side effects. This study compares different dosing strategies to find the safest and most effective tapering schedule. **You may be eligible if...** - You are 18 or older - You have a brain tumor (including high-grade glioma, low-grade glioma, meningioma, or brain metastasis) that has been identified on imaging and you are having brain surgery **You may NOT be eligible if...** - You have a known disorder of the hypothalamus, pituitary gland, or adrenal axis - You have a significant immune deficiency - You are on strong immunosuppressive drugs - You have a current lymphoma or leukemia - You have had a prior organ transplant - You are pregnant - You have had a prior stroke that left a neurological deficit - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

DRUGDexamethasone

Given dexamethasone or IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT06132685


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