NCT06710249 Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
| NCT ID | NCT06710249 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peter Siesjö |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-27 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-01-27 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06710249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06710249 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06710249 currently recruiting?
Yes, NCT06710249 is actively recruiting participants. Contact the research team at peter.siesjo@med.lu.se for enrollment information.
Where is the NCT06710249 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT06710249 clinical trial?
NCT06710249 is sponsored by Peter Siesjö. The trial plans to enroll 20 participants.
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