Trial Title:
Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
NCT ID:
NCT06132685
Condition:
Low Grade Glioma
Malignant Brain Glioma
Malignant Brain Neoplasm
Meningioma
Conditions: Official terms:
Glioma
Brain Neoplasms
Meningioma
Dexamethasone
Dexamethasone acetate
Ichthammol
BB 1101
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (NDS)
Arm group label:
Arm II (RDS)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Arm I (NDS)
Arm group label:
Arm II (RDS)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Given dexamethasone or IV
Arm group label:
Arm I (NDS)
Arm group label:
Arm II (RDS)
Other name:
Aacidexam
Other name:
Adexone
Other name:
Aknichthol Dexa
Other name:
Alba-Dex
Other name:
Alin
Other name:
Alin Depot
Other name:
Alin Oftalmico
Other name:
Amplidermis
Other name:
Anemul mono
Other name:
Auricularum
Other name:
Auxiloson
Other name:
Baycadron
Other name:
Baycuten
Other name:
Baycuten N
Other name:
Cortidexason
Other name:
Cortisumman
Other name:
Decacort
Other name:
Decadrol
Other name:
Decadron
Other name:
Decadron DP
Other name:
Decalix
Other name:
Decameth
Other name:
Decasone R.p.
Other name:
Dectancyl
Other name:
Dekacort
Other name:
Deltafluorene
Other name:
Deronil
Other name:
Desamethasone
Other name:
Desameton
Other name:
Dexa-Mamallet
Other name:
Dexa-Rhinosan
Other name:
Dexa-Scheroson
Other name:
Dexa-sine
Other name:
Dexacortal
Other name:
Dexacortin
Other name:
Dexafarma
Other name:
Dexafluorene
Other name:
Dexalocal
Other name:
Dexamecortin
Other name:
Dexameth
Other name:
Dexamethasone Intensol
Other name:
Dexamethasonum
Other name:
Dexamonozon
Other name:
Dexapos
Other name:
Dexinoral
Other name:
Dexone
Other name:
Dinormon
Other name:
Dxevo
Other name:
Fluorodelta
Other name:
Fortecortin
Other name:
Gammacorten
Other name:
Hemady
Other name:
Hexadecadrol
Other name:
Hexadrol
Other name:
Lokalison-F
Other name:
Loverine
Other name:
Methylfluorprednisolone
Other name:
Millicorten
Other name:
Mymethasone
Other name:
Orgadrone
Other name:
Spersadex
Other name:
TaperDex
Other name:
Visumetazone
Other name:
ZoDex
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm I (NDS)
Arm group label:
Arm II (RDS)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (NDS)
Arm group label:
Arm II (RDS)
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.
Detailed description:
PRIMARY OBJECTIVES:
I. The primary objective of this study is to evaluate the efficacy of a reduced dosage
steroid schedule (RDS) in patients who have undergone craniotomy for high grade glioma
(HGG), low grade glioma (LGG), brain metastasis (BM), and meningiomas as compared with
the normal dosing schedule (NDS).
II. RDS after undergoing craniotomy for brain tumor has no impact on length of stay, 30
day readmission, and need for repeat imaging when compared to NDS.
SECONDARY OBJECTIVE:
I. RDS after craniotomy for brain tumor has no impact on development of steroid related
side effects (new onset or worsening hypertension, hyperglycemia, wound infection,
impaired wound healing, steroid dependence, neuropsychiatric disturbance) when compared
to NDS.
TERTIARY/EXPLORATORY OBJECTIVE:
I. RDS after craniotomy has no effect on lymphocyte count and differential at 10-14 days
after surgery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (NDS): 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 magnetic resonance imaging (MRI) and computed tomography (CT) scan
during inpatient stay as part of standard of care.
ARM II (RDS): Patients receive tapering doses of dexamethasone on days 1-4. Patients may
receive dexamethasone intravenously (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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Agnes Harutyunyan
Email:
aharuty@emory.edu
Investigator:
Last name:
Kimberly Hoang, MD
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
July 30, 2028
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06132685
