Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
AFBTEdema
1 other identifier
interventional
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2024
CompletedFirst Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJanuary 27, 2025
January 1, 2025
1.9 years
November 25, 2024
January 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of neurological symptoms
To investigate whether Salovum® and SPC® flakes can change neurological symptoms in participants with tumor induced cerebral oedema as measured by the neurologic assessment in neurooncology (NANO) scale (range 0-23, 0 best-23 worst)
28 days
Secondary Outcomes (1)
Change of cerebral edema
28 days
Other Outcomes (3)
Change of symptoms from cerebral oedema in steroid naive participants
28 days
Change of symptoms from cerebral oedema in steroid refractory cerebral oedema
28 days
Change of symptoms from cerebral oedema in participants with diverse tumor types
28 days
Study Arms (1)
Salovum/SPC flakes
EXPERIMENTALInterventions
Egg yolk powder and specially processed cereals
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter Siesjölead
- Lund Universitycollaborator
Study Sites (1)
Department of Neurosurgery
Lund, 22185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant, MD, PhD
Study Record Dates
First Submitted
November 25, 2024
First Posted
November 29, 2024
Study Start
January 27, 2024
Primary Completion
January 1, 2026
Study Completion
March 1, 2026
Last Updated
January 27, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share