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

Study acronym: AFBTEdema
StatusRecruiting
PhasePhase 2
Started
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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.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Primary completion date: Dec 13, 2025 to Jan 2026
    • Study completion date: Dec 13, 2025 to Mar 1, 2026
    • Start date changed from estimate of Dec 13, 2024 to Jan 27, 2024
    • Secondary endpoint revised
    • Study title revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Peter Siesjö
4 trials monitored
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Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
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
Trial Details
NCT Number NCT06710249
Lead Sponsor Peter Siesjö
Collaborators: Lund University
Conditions
(from sponsor)		 Glioblastoma, Cerebral Metastases, Meningioma
Related terms Brain Edema, Glioblastoma, Meningioma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov