Effects of Salovum® and SPC® Flakes on Brain Tumor Edema
Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
PHASE2 · Skane University Hospital · NCT06710249
This study is testing if eating Salovum® and SPC® flakes can help reduce swelling in the brain and improve symptoms for people with certain types of brain tumors.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Skane University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lund) |
| Trial ID | NCT06710249 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Salovum®, an egg yolk powder rich in antisecretory factor, and SPC® flakes, processed oats, on cerebral edema caused by brain tumors. Participants will consume these products over a 28-day period while their neurological and cognitive symptoms, as well as MRI changes in edema, will be monitored. The study aims to determine if these interventions can reduce both clinical symptoms and radiological evidence of edema in patients with glioblastoma, cerebral metastases, or meningiomas. The trial also explores the effects in patients who are either steroid refractory or naïve.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-79 with a known or suspected brain tumor causing edema and who are able to provide informed consent.
Not a fit: Patients with an egg yolk allergy or significant midline shift may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less toxic alternative to corticosteroids for managing cerebral edema in brain tumor patients.
How similar studies have performed: While the use of antisecretory factor in this context is novel, previous studies have shown its effectiveness in reducing intracranial pressure in other models.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lund
- Department of Neurosurgery — Lund, Sweden (RECRUITING)
Study contacts
- Study coordinator: Peter Siesjö, MD, PhD
- Email: peter.siesjo@med.lu.se
- Phone: +46705655778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioblastoma, Cerebral Metastases, Meningioma, cerebral edema, antisecretory factor