Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
NCT06132685 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-02-10
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.
Conditions
- Low Grade Glioma
- Malignant Brain Glioma
- Malignant Brain Neoplasm
- Meningioma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- DRUG
-
Given dexamethasone or IV
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Emory University
lead OTHER
Principal Investigators
-
Kimberly Hoang, MD · Emory University Hospital/Winship Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-09
- Primary Completion
- 2027-07-30
- Completion
- 2028-07-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
NCT03125941 ·Status: COMPLETED ·Phase: PHASE4
-
The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels
NCT01524731 ·Status: COMPLETED ·Phase: NA
-
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
NCT02550795 ·Status: COMPLETED ·Phase: NA
-
Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer
NCT04350229 ·Status: COMPLETED ·Phase: NA
-
Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
NCT01275664 ·Status: TERMINATED ·Phase: NA
-
Reducing Dexamethasone Around Docetaxel Infusion
NCT02776436 ·Status: COMPLETED ·Phase: PHASE1
-
Dexamethasone for Symptom Burden in Advanced Cancer Patients
NCT00489307 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
NCT01013012 ·Status: COMPLETED ·Phase: PHASE4
-
Dexamethasone Dyspnea Study
NCT01670097 ·Status: COMPLETED ·Phase: PHASE2
-
Dexamethasone Palmitate for PONV After Open Surgery
NCT06997419 ·Status: RECRUITING ·Phase: NA
-
Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome
NCT02846493 ·Status: UNKNOWN ·Phase: PHASE2
-
Effect of Dexamethasone in Postoperative Symptoms After Mastectomy for Breast Cancer
NCT01116713 ·Status: COMPLETED ·Phase: PHASE3
-
Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
NCT06269900 ·Status: RECRUITING ·Phase: PHASE3
-
Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin
NCT02382068 ·Status: WITHDRAWN ·Phase: NA
-
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
NCT00424242 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen
NCT01490060 ·Status: COMPLETED ·Phase: NA
-
Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting
NCT01975727 ·Status: TERMINATED ·Phase: PHASE2
-
Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin
NCT04201769 ·Status: UNKNOWN ·Phase: PHASE3
-
Dexamethasone for Palliation - Brain Metastases
NCT00188864 ·Status: COMPLETED ·Phase: PHASE2
-
Glucose Variability in Cancer Patients Receiving Dexamethasone
NCT02372539 ·Status: WITHDRAWN
-
Dexamethasone in Controlling Dyspnea in Patients With Cancer
NCT03367156 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction
NCT02349763 ·Status: COMPLETED ·Phase: PHASE3
-
Anti-emetic Prophylaxis With or Without Dexamethasone
NCT05242874 ·Status: COMPLETED ·Phase: PHASE3
-
A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery
NCT03109990 ·Status: COMPLETED ·Phase: NA
-
Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)
NCT00687011 ·Status: COMPLETED ·Phase: PHASE4