Dexamethasone dosing after brain tumor surgery
Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
This study is testing if a lower dose of dexamethasone after brain tumor surgery can help reduce side effects for patients compared to the usual dose.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | adalimumab, infliximab, methotrexate |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06132685 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effects of tapering doses of dexamethasone on reducing steroid side effects in patients who have undergone craniotomy for brain tumors. The study compares a reduced dosage steroid schedule (RDS) with a normal dosing schedule (NDS) to assess efficacy and safety. Patients will be randomized into two arms, with one group receiving the standard tapering doses and the other receiving a reduced tapering schedule. The trial also includes assessments of length of hospital stay, readmission rates, and side effects related to steroid use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with radiographic findings consistent with high-grade glioma, low-grade glioma, meningioma, or brain metastasis.
Not a fit: Patients with known hypothalamic-pituitary-adrenal axis dysfunction or those currently taking immunosuppressive drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could minimize steroid-related side effects while effectively managing post-operative edema in brain tumor patients.
How similar studies have performed: Other studies have explored steroid dosing in post-operative settings, but this specific tapering approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Hoang, MD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Kimberly Hoang, MD
- Email: kbhoang@emory.edu
- Phone: 404-778-5770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.