Withholding Dexamethasone for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety of omitting dexamethasone, a steroid, during surgery for patients with newly diagnosed brain tumors that have metastasized. The main goal is to determine if patients can undergo brain surgery without this medication, which often reduces swelling. Suitable candidates have new brain tumors and a suspected or confirmed cancer elsewhere, such as a lung mass, and plan to have surgery to remove at least 75% of the brain tumor. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance surgical outcomes and reduce medication use.
What prior data suggests that withholding dexamethasone is safe for brain cancer patients?
Research shows that dexamethasone has been used for over 40 years to reduce brain swelling in cancer patients, especially those with brain tumors. It effectively manages symptoms, but some studies suggest that using less or gradually stopping it can lower side effects like high blood pressure, without increasing hospital visits or longer stays.
This trial examines the effects of not using dexamethasone during surgery for cancer that has spread to the brain. While dexamethasone is often helpful, the study aims to determine if skipping it is safe in certain cases.
Overall, dexamethasone is known to work well, but this trial will determine if it can be safely omitted during surgery. Participants should know that dexamethasone is usually well-tolerated, and the study will assess the safety of not using it.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the safety of skipping dexamethasone, a steroid commonly used to reduce swelling and inflammation in brain cancer patients. Unlike typical treatments that rely on steroids to manage symptoms, this trial investigates whether patients can safely undergo surgery for brain metastases without the potential side effects of dexamethasone, such as weakened immune response and blood sugar spikes. This could lead to a more streamlined treatment approach with fewer side effects, improving overall patient well-being during a critical time.
What evidence suggests that withholding dexamethasone is safe for brain cancer patients?
Research has shown that dexamethasone reduces brain swelling and eases neurological symptoms in people with brain tumors. Studies have found that patients often feel better within 1–3 days of starting treatment. One study suggested that lower doses of dexamethasone after surgery might be sufficient, indicating flexibility in dosage. However, participants in the current trial will join an arm investigating the safety of avoiding dexamethasone during surgery for brain metastases. The primary concern is safety, as dexamethasone is commonly used to manage symptoms effectively.56789
Who Is on the Research Team?
Akshitkumar Mistry, MD
Principal Investigator
University of Louisville
Are You a Good Fit for This Trial?
This trial is for adults with new brain tumors and suspected cancerous masses elsewhere in the body, who can undergo brain surgery without issues. They should be mostly active (ambulatory over half of their waking hours) and have a midline shift on MRI of 10 mm or less. Those with certain lung cancers needing biopsy before brain tumor removal are also eligible.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo resection of brain metastases without perioperative dexamethasone
Follow-up
Participants are monitored for safety and effectiveness after surgery, including assessment of lymphopenia and need for dexamethasone rescue
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Trial Overview
The MeDex trial is studying the effects of not using Dexamethasone, a common anti-inflammatory medication, during the perioperative period when patients with newly diagnosed brain metastases from other cancers undergo surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The safety and feasibility of withholding perioperative dexamethasone (Dex) in newly diagnosed cancer patients undergoing resection of brain metastases (BMs). The primary question is not comparative efficacy, but rather whether it is safe to forgo Dex in this patient population.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
Citations
INNV-25. POST-OPERATIVE LOW DOSE VERSUS ...
CONCLUSIONS. Administration of lower doses of dexamethasone post-operatively to brain tumor patients with mild to moderate cerebral edema is feasible. Treatment ...
Management of complications from brain metastasis treatment
However, in the outpatient setting, a reasonable starting dose of dexamethasone is 2 to 4 mg PO BID. Clinical improvement typically occurs within 1–3 days, ...
Study Details | NCT05139043 | Low Dose Versus Standard ...
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery.
A multidisciplinary management algorithm for brain metastases
A multidisciplinary management algorithm for brain metastases that incorporates the latest advances in surgery, radiation therapy, and systemic therapy.
Dexamethasone treatment in patients with brain ...
Dexamethasone effectively minimizes neurological symptoms and RT-related side-effects in patients with primary and secondary brain tumors.
Corticosteroids in brain cancer patients: benefits and pitfalls
More than 40 years ago, it was demonstrated that dexamethasone effectively alleviated cerebral edema due to brain tumors [1], which eventually revolutionized ...
The story of dexamethasone and how it became one of the ...
These findings would make it unethical to withhold dexamethasone in patients undergoing brain tumor resection, and the FDA soon authorized its ...
Low Dose Versus Standard Dose Dexamethasone for ...
This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling. Detailed ...
A Reduced Exogenous Steroid Taper for Postoperative ...
A reduced steroid taper after brain tumor surgery significantly reduced the incidence of hypertension without increasing LOS or 30-day readmissions.
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