Clinical trial NCT06132685: Post-Operative Dosing of Dexamethasone in Patients with Brain Tumors After a Craniotomy, PODS Trial
Official title: Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Low Grade Glioma
Malignant Brain Glioma
Malignant Brain Neoplasm
Meningioma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Up to 3 months
measure: 30-day repeat admission rate
timeFrame: At 30 days after surgery
measure: Need for repeat head imaging
timeFrame: Up to 3 months
Secondary outcomes:
measure: Incidence of new neurologic deficit
timeFrame: At less than 30 days and at 3 months
measure: Breakthrough seizures
timeFrame: Up to 30 days after surgery
measure: Evidence of Worsening Cerebral Edema
timeFrame: Between 5 and 30 days after surgery
measure: Evaluation for Steroid Dependence
timeFrame: At long term follow up to 3 months after surgery
measure: Rate of new onset hypertension
timeFrame: During inpatient stay up to 3 months after surgery
measure: Rate of new onset hyperglycemia
timeFrame: During inpatient stay up to 3 months after surgery
measure: Evaluation for Wound infection or Delayed Wound Healing
timeFrame: At 2 week wound check after surgery
measure: Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects
timeFrame: At 2 week follow up after surgery
measure: Change in lymphocyte count and differential
timeFrame: At baseline and 10-14 days post-operative
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Kimberly Hoang, MD
role: PRINCIPAL_INVESTIGATOR
References: