Clinical trial · Interventional
Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Metastases | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salovum/SPC flakes | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Salovum/SPC flakes
- interventionNames
- Dietary Supplement: Salovum/SPC flakes
Primary outcomes (1)
- measure
- Change of neurological symptoms
- timeFrame
- 28 days
- description
- 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)
Secondary outcomes (1)
- measure
- Change of cerebral edema
- timeFrame
- 28 days
- description
- To investigate whether Salovum® and SPC® flakes can change radiological signs of edema in participants with tumor induced cerebral oedema
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-79 years 2. Known or radiologically suspected primary or secondary brain tumor (suspected metastasis, meningioma, glioma, etc.) with surrounding edema causing clinical signs 3. GCS 14-15 4. WHO ECOG performance status 0-2 5. Planned or started cortisone treatment 6. Ability to provide informed consent Exclusion Criteria: 1. Egg yolk allergy 2. Midline shift \>5mm 3. GCS ≤13 4. Epilepsy as sole symptom from the cerebral edema
References
Publications (0)
Data not yet available