Actively Recruiting
Post-Operative Dosing of Steroids After Craniotomy for Brain Tumor Comparing Reduced and Normal Dexamethasone Schedules
Led by Emory University · Updated on 2026-02-10
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of reducing doses of dexamethasone, a corticosteroid, on side effects in patients after brain tumor surgery (craniotomy). This phase II trial focuses on patients with high grade glioma, low grade glioma, brain metastasis, and meningiomas. The study aims to compare a reduced dosage steroid schedule (RDS) with the normal dosing schedule (NDS) to see if tapering steroids more quickly affects hospital stay length, readmission rates, and the need for repeat imaging. Participants are randomly assigned to one of two groups. One group receives tapering doses of dexamethasone over 15 days (normal dosing schedule), while the other receives tapering doses over 4 days (reduced dosage schedule). Blood samples are collected at surgery and follow-up visits, with optional wound checks 10-14 days after surgery. MRI and CT scans are performed during inpatient stay as part of standard care. The reduced dosage group may receive intravenous dexamethasone and restart the taper if needed. During the study, participants will be monitored for neurological symptoms, steroid side effects like high blood pressure and high blood sugar, wound healing, and lymphocyte counts. Researchers will track hospital stay duration, 30-day readmission, repeat imaging needs, and other health outcomes up to three months after surgery. Safety assessments include checking for seizures, cerebral edema, psychiatric effects, and infections, with follow-up visits and questionnaires. The study may last until July 2028.
CONDITIONS
Brief Title
Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with radiographic findings consistent with high grade glioma, low grade glioma, meningioma, or brain metastasis
- Age 18 years or older
You will not qualify if you...
- Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction
- Tumor causing compression of the sella or pituitary dysfunction
- Known immunodeficiency including severe combined immunodeficiency, common variable immunodeficiency, or lymphocytopenia
- Taking immunosuppressive drugs such as methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab
- More than two weeks of recent daily corticosteroid use or corticosteroids equivalent to more than 85 mg dexamethasone in the last month
- Current lymphoma or leukemia
- History of solid organ transplant
- Under 18 years old
- Pregnant women
- History of cerebrovascular accident causing neurological deficit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay (up to 3 months)
Participants undergo craniotomy for brain tumor and receive blood sample collection, MRI, and CT scans as part of standard inpatient care.
During inpatient stay
Duration - Days 1 to 15 or days 1 to 4 with possible extension
Participants receive tapering doses of dexamethasone. Arm I participants follow a dosing schedule from days 1 to 15, while Arm II participants follow a reduced dosing schedule from days 1 to 4 with possible intravenous dosing and taper restart if needed.
Blood samples collected at surgery and follow-up visits; optional wound check visit 10-14 days post-operative
Duration - Up to 3 months after surgery
Participants attend follow-up visits to monitor recovery, collect blood samples, evaluate for steroid side effects, wound healing, neuropsychiatric symptoms, and to undergo optional wound check visits 10-14 days after surgery.
Follow-up visits including wound check visit 10-14 days post-operative
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
K
Kimberly Hoang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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