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Post-Operative Dexamethasone for Brain Cancer

Phase 2

Waitlist Available

Led By Kimberly Hoang, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis

Age equal to or above 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial tests if tapering doses of steroids can reduce side effects without worsening edema in brain tumor patients after surgery.

Who is the study for?

This trial is for adults over 18 who've had surgery to remove a brain tumor and have radiographic findings consistent with certain types of tumors. It's not for those under 18, pregnant women, people with specific immune or hormonal disorders, recent heavy corticosteroid use, or a history of solid organ transplant.Check my eligibility

What is being tested?

The PODS Trial is testing whether decreasing doses of dexamethasone can reduce its side effects without increasing swelling risks after brain tumor surgery. The study involves CT scans, MRIs, biospecimen collection, and questionnaires to monitor outcomes.See study design

What are the potential side effects?

Dexamethasone may cause high blood sugar levels, increased blood pressure, difficulty in wound healing among other potential side effects related to its class as a corticosteroid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain scans show I might have a high-grade glioma, low-grade glioma, meningioma, or brain metastasis.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

30-day repeat admission rate

Length of hospital stay

Need for repeat head imaging

Secondary outcome measures

Breakthrough seizures

Change in lymphocyte count and differential

Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (RDS)Experimental Treatment5 Interventions

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.

Group II: Arm I (NDS)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Dexamethasone

2007

Completed Phase 4

~2590

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,642 Previous Clinical Trials

2,563,702 Total Patients Enrolled

1 Trials studying Meningioma

70 Patients Enrolled for Meningioma

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,171 Total Patients Enrolled

45 Trials studying Meningioma

4,037 Patients Enrolled for Meningioma

Kimberly Hoang, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Arm II (RDS) for public usage?

"Our team at Power rated Arm II (RDS) a 2 due to the existing evidence of safety, but lack of data on efficacy."

Answered by AI

Are recruitment efforts still underway for this experiment?

"Clinicaltrials.gov indicates that this medical trial is not currently enrolling any new participants, despite first being posted on December 1st 2023 and edited as recently as November 7th 2023. There are still 777 other clinical trials actively taking in patients at the present moment."

Answered by AI

What objectives is this research endeavor striving to fulfill?

"This clinical trial, which is set to run for up to three months, aims to measure the length of hospital stay. Secondary objectives involve gauging incidence of new neurologic deficit with Fisher exact test or Chi-Square test and logistic regression; evaluating prevalence of breakthrough seizures through similar statistical methods; and assessing severity of cerebral edema on a 3 point scale courtesy of neuroradiology readings from CT scans without contrast imaging."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kimberly Bojanowski Hoang 2024. "Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132685.

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