Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
Peter Siesjö
20 participants
Jan 27, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria6
- Age 18-79 years
- Known or radiologically suspected primary or secondary brain tumor (suspected metastasis, meningioma, glioma, etc.) with surrounding edema causing clinical signs
- GCS 14-15
- WHO ECOG performance status 0-2
- Planned or started cortisone treatment
- Ability to provide informed consent
Exclusion Criteria4
- Egg yolk allergy
- Midline shift \>5mm
- GCS ≤13
- Epilepsy as sole symptom from the cerebral edema
Interventions
Egg yolk powder and specially processed cereals
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06710249