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NCT Number: NCT06132685

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

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.

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Key information

Conditions

Low Grade Glioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Malignant Brain Glioma Malignant Brain Neoplasm Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location status: Recruiting

Location contact

Agnes Harutyunyan

CONTACT

[email protected]

Kimberly Hoang, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Computed Tomography

Procedure

Undergo CT scan

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Dexamethasone

Drug

Given dexamethasone or IV

Other names: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Length of hospital stay

    Time frame: Up to 3 months

    The two-sample t-test or Mann-Whitney U test utilized to estimate the differences between the two groups. General linear model employed in the multivariable analysis to estimate the adjusted difference in length of hospital stay between the two groups after adjusting for other factors.

  2. 30-day repeat admission rate

    Time frame: At 30 days after surgery

    Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. Odds ratios (OR) and 95% confidence intervals (CIs) calculated to evaluate the strength of any association.

  3. Need for repeat head imaging

    Time frame: Up to 3 months

    Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.

Secondary outcomes

  1. Incidence of new neurologic deficit

    Time frame: At less than 30 days and at 3 months

    Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.

  2. Breakthrough seizures

    Time frame: Up to 30 days after surgery

    Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.

  3. Evidence of Worsening Cerebral Edema

    Time frame: Between 5 and 30 days after surgery

    This measure will be a three-level scale determined by the final neuroradiology read of comparison imaging as either improved cerebral edema, stable cerebral edema, or worsened cerebral edema when evaluated on repeat CT Head without contrast.

  4. Evaluation for Steroid Dependence

    Time frame: At long term follow up to 3 months after surgery

    This measure will be evaluated in a binary manner as either the patient having been successfully weaned off of all steroids or the patient remaining on supplemental daily steroids due to the inability to wean off of steroids due to symptomatic adrenal insufficiency. The assessment of adrenal insufficiency will not be done as part of this the study, this study will document the continued use of supplemental daily steroids at 3 month follow-up versus not.

  5. Rate of new onset hypertension

    Time frame: During inpatient stay up to 3 months after surgery

    Defined as sustained systolic blood pressure > 140. Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.

  6. Rate of new onset hyperglycemia

    Time frame: During inpatient stay up to 3 months after surgery

    Defined as random blood glucose > 100 and/or new insulin requirement. Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.

  7. Evaluation for Wound infection or Delayed Wound Healing

    Time frame: At 2 week wound check after surgery

    This criterion will be assessed via the "Wound Check Form" which uses a scale from 1-9 with worsening wound healing and infection indicated by an increased score. Modifiers A and B indicating cellulitis and purulence respectively are also added to the scale. The worst score on this scale would therefore be a 9AB, and a perfectly healed wound would be score of 1.

  8. Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects

    Time frame: At 2 week follow up after surgery

    This criterion will be initially assessed via EPIC documentation via daily assessment via Neurosurgery residents whether the patient has experienced severe new onset behavioral issues in the post-op period typically associated with steroids (agitation, psychosis, mania). This will be then categorized into a binary system determining either the presence or absence of new severe agitation, psychosis, or mania. In addition, at the post operative visit, the patient will fill out the 'Dexamethasone Symptom questionnaire' which is a standardized questionnaire recording binary presence vs no presence of a list of common subjective symptoms experienced by patients on chronic steroids (headache, changes in body habitus etc) which will additionally be recorded.

  9. Change in lymphocyte count and differential

    Time frame: At baseline and 10-14 days post-operative

    Compared using the two-sample t-test. A general linear model will be used in the multivariable analysis to estimate the adjusted difference.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Hoang, MD

CONTACT

[email protected]

404-778-5770

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 15, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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