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Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema

RECRUITINGPhase 2Sponsored by Peter Siesjö
Actively Recruiting
PhasePhase 2
SponsorPeter Siesjö
Started2024-01-27
Est. completion2026-01
Eligibility
Age18 Years – 79 Years
Healthy vol.Accepted

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

Age: 18 Years – 79 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Age 18-79 years
2. Known or radiologically suspected primary or secondary brain tumor (suspected metastasis, meningioma, glioma, etc.) with surrounding edema causing clinical signs
3. GCS 14-15
4. WHO ECOG performance status 0-2
5. Planned or started cortisone treatment
6. Ability to provide informed consent

Exclusion Criteria:

1. Egg yolk allergy
2. Midline shift \>5mm
3. GCS ≤13
4. Epilepsy as sole symptom from the cerebral edema

Conditions4

CancerCerebral MetastasesGlioblastomaMeningioma

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