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

Plain Language Summary

Simplified for easier understanding

This study is testing whether two specific nutritional supplements (Salovum and SPC Flakes) can help reduce brain swelling (edema) in patients with brain tumors who are already receiving steroids. **You may be eligible if...** - You are between 18 and 79 years old - You have a known or suspected brain tumor (such as glioma, meningioma, or brain metastasis) with surrounding swelling causing symptoms - You are conscious and alert (GCS 14 or 15) - You are already receiving or about to start steroid (cortisone) treatment for the swelling - You can give informed consent **You may NOT be eligible if...** - You are allergic to egg yolk (a component of one supplement) - Your brain is significantly shifted due to swelling (midline shift over 5 mm) - You have epilepsy as the only symptom from the brain swelling - Your level of consciousness is reduced (GCS 13 or below) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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