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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Department of Neurosurgery
RECRUITING
Lund
Contact Information
Primary
Peter Siesjö, MD, PhD
peter.siesjo@med.lu.se
+46705655778
Backup
Erik Ehinger, MD
erik.ehinger@med.lu.se
+46707970783
Time Frame
Start Date: 2024-01-27
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 20
Treatments
Experimental: Salovum/SPC flakes
Sponsors
Leads: Peter Siesjö
Collaborators: Lund University

This content was sourced from clinicaltrials.gov