RecruitingPhase 2NCT06710249

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


Sponsor

Peter Siesjö

Enrollment

20 participants

Start Date

Jan 27, 2024

Study Type

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

Min Age: 18 YearsMax Age: 79 Years

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

DIETARY_SUPPLEMENTSalovum/SPC flakes

Egg yolk powder and specially processed cereals


Locations(1)

Department of Neurosurgery

Lund, Sweden

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NCT06710249


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