Fact CheckerSign in

NCT06710249RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
First submitted
25 Nov 2024
Start date
27 Jan 2024
Primary completion date
Jan 2026
Lead sponsor
Peter Siesjö
Diseases
Glioblastoma
NCT number
NCT06710249

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 20
  • From 27 Jan 2024 to the primary completion date, Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Egg yolk allergy
  • Epilepsy as sole symptom from the cerebral edema

Other

  • Midline shift \>5mm
  • GCS ≤13

Who the study is looking for

  • 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

Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Neurosurgery
Coordinator of this site? Confirm its status
LundSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.