Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or… (NCT05139043) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or Metastatic Brain Tumors
United States26 participantsStarted 2022-04-09
Plain-language summary
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part of the treatment of brain tumors; however, it results in injury to surrounding brain tissue, leading to brain swelling. Dexamethasone is effective for controlling the swelling of the brain; however, dexamethasone can cause many unwanted side effects. To minimize the side effects of dexamethasone, the lowest dose needed to control swelling of the brain should be used. This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is 18 years or older.
* Participant has a Karnofsky Performance Status of \>= 60%.
* Participant has a primary or metastatic brain tumor(s).
* Participant can have newly diagnosed or recurrent brain tumor(s).
* If a participant is requiring more than 3 mg orally every 12 hours (q 12 h) of dexamethasone at the time of signing the consent form, it is anticipated by the neurosurgeon that the participant will be able to taper down their dose of dexamethasone to 3 mg orally q 12 h by 3 days before the surgery.
* (Note: If the patient is not able to decrease their dose of dexamethasone to 3 mg orally q 12 h 3 days before surgery, the patient will not be allowed to participate in the study.)
* Participant must have less than 10 mm of midline shift seen on pre-op brain magnetic resonance imaging (MRI).
* The neurosurgeon anticipates being able to perform a gross total resection of tumor.
* Participant is not planning to participate in another clinical trial during the study period.
* There is no limit to the number of prior therapies for enrollment in this study.
* All participants must have the ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Participant is unable to undergo a brain MRI.
* Participant is unable to tolerate dexamethasone.
* Participant has a chronic or active viral infection of the central nervous system (CNS).
* Participant has a coagulopathy or bleeding disorder.
* Participan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.