RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-09
Study Completion:2028-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06132685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis
  2. * Age equal to or above 18
  1. * Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction
  2. * Tumor causing compression of the sella or pituitary dysfunction
  3. * Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia
  4. * 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
  5. * Current lymphoma or leukemia
  6. * History of solid organ transplant
  7. * Minors \< 18
  8. * Pregnant women
  9. * History of cerebrovascular accident leading to neurologic deficit

Contacts and Locations

Study Contact

Kimberly Hoang, MD
CONTACT
404-778-5770
kbhoang@emory.edu

Principal Investigator

Kimberly Hoang, MD
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Kimberly Hoang, MD, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-09
Study Completion Date2028-07-30

Study Record Updates

Study Start Date2025-01-09
Study Completion Date2028-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Low Grade Glioma
  • Malignant Brain Glioma
  • Malignant Brain Neoplasm
  • Meningioma