Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
Recruiting now · Phase 2
Conditions studied: Glioblastoma, Cerebral Metastases, Meningioma
In brief
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
Key facts
- Study ID
- NCT06710249
- Run by
- Peter Siesjö
- People needed
- 20
- Starts
- 2024-01-27
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-01-27
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Egg yolk allergy
- Midline shift >5mm
- GCS ≤13
- Epilepsy as sole symptom from the cerebral edema
Where it is running
- Department of Neurosurgery — Lund, Sweden (enrolling)
Full record on ClinicalTrials.gov
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