Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Computed Tomography, Dexamethasone, Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Low Grade Glioma, Malignant Brain Glioma, Malignant Brain Neoplasm, Meningioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo blood sample collection - Procedure Computed Tomography
Undergo CT scan - Drug Dexamethasone
Given dexamethasone or IV - Procedure Magnetic Resonance Imaging
Undergo MRI - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Length of hospital stay [Time frame: Up to 3 months]
- 30-day repeat admission rate [Time frame: At 30 days after surgery]
- Need for repeat head imaging [Time frame: Up to 3 months]
Secondary outcome measures (9)
- Incidence of new neurologic deficit [Time frame: At less than 30 days and at 3 months]
- Breakthrough seizures [Time frame: Up to 30 days after surgery]
- Evidence of Worsening Cerebral Edema [Time frame: Between 5 and 30 days after surgery]
- Evaluation for Steroid Dependence [Time frame: At long term follow up to 3 months after surgery]
- Rate of new onset hypertension [Time frame: During inpatient stay up to 3 months after surgery]
- Rate of new onset hyperglycemia [Time frame: During inpatient stay up to 3 months after surgery]
- Evaluation for Wound infection or Delayed Wound Healing [Time frame: At 2 week wound check after surgery]
- Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects [Time frame: At 2 week follow up after surgery]
- Change in lymphocyte count and differential [Time frame: At baseline and 10-14 days post-operative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Emory University Hospital/Winship Cancer Institute — Atlanta
Identifiers
NCT: NCT06132685 · STUDY00003975 · NCI-2023-04702 · STUDY00003975 · WINSHIP5678-22 · P30CA138292