Actively Recruiting
Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
Led by Peter Siesjö · Updated on 2025-01-27
20
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
P
Peter Siesjö
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this clinical trial is to explore the effects of Salovum®, an egg yolk powder enriched with the endogenous protein antisecretory factor, and SPC® flakes , hydrothermically processed oats, on cerebral edema with clinical symptoms in participants with brain tumors. The primary questions the trial seeks to answer are: * Can Salovum® and SPC® flakes have effect on clinical symptoms of tumor-induced cerebral edema? * Can Salovum® and SPC® flakes induce regression of radiological edema in tumor-induced cerebral edema Additionally, the study will investigate the impact of Salovum® and SPC® flakes in steroid refractory, steroid naïve cerebral edema and type of barin tumor Researchers will: Evaluate edema change from baseline by MRI after 14 days Evaluate neurological and cognitive symptoms Register dose of steroid medications Participants will: * Ingest Salovum® 11g three times daily for 14 days, thereafter tapered during 14 days * Ingest SPC® flakes 1g/kg daily from day 7
CONDITIONS
Official Title
Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 79 years
- Known or suspected primary or secondary brain tumor with surrounding edema causing clinical signs
- Glasgow Coma Scale (GCS) between 14 and 15
- WHO ECOG performance status 0 to 2
- Planned or started cortisone treatment
- Ability to provide informed consent
You will not qualify if you...
- Allergy to egg yolk
- Midline brain shift greater than 5 mm
- Glasgow Coma Scale (GCS) 13 or lower
- Epilepsy as the only symptom from the cerebral edema
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Neurosurgery
Lund, Sweden, 22185
Actively Recruiting
Research Team
P
Peter Siesjö, MD, PhD
CONTACT
E
Erik Ehinger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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