Clinical Trial

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

Study acronym: AFBTEdema
Recruiting Phase 2
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Record status
This record was last updated January 27, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-25.
Status change: Not Yet Recruiting → Recruiting 2025-01-22
Trial Details
NCT Number NCT06710249
Lead Sponsor Peter Siesjö
Collaborators: Lund University
Conditions Glioblastoma, Cerebral Metastases, Meningioma
Enrollment 20 participants
Start Date 2024-01-27
Primary Completion 2026-01 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-27