NCT06132685 Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
| NCT ID | NCT06132685 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | Low Grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-01-09 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Kimberly Hoang, MD
PRINCIPAL INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Frequently Asked Questions
Who can join the NCT06132685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06132685 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06132685 currently recruiting?
Yes, NCT06132685 is actively recruiting participants. Contact the research team at kbhoang@emory.edu for enrollment information.
Where is the NCT06132685 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT06132685 clinical trial?
NCT06132685 is sponsored by Emory University. The principal investigator is Kimberly Hoang, MD at Emory University Hospital/Winship Cancer Institute. The trial plans to enroll 200 participants.