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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.