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NCT06710249: AFBTEdema
Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
Phase 2 trial testing Salovum/SPC flakes in Glioblastoma in 20 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Peter Siesjö |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 27 January 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 March 2026 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Salovum/SPC flakes
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
- Cerebral Metastases — all drugs for Cerebral Metastases →
- Meningioma — all drugs for Meningioma →
Sponsor
Peter Siesjö
Who can join
Adults 18 to 79, any sex, with Glioblastoma or Cerebral Metastases. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change of neurological symptoms
Time frame: 28 days
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)
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06710249
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07480941 — Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma · Phase 1 · recruiting
- NCT07448480 — Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas · active not recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Peter Siesjö trials
Trials by the same sponsor.
- NCT05669820 — Antisecretory Factor Glioblastoma Phase 2 · Phase 2, PHASE3 · recruiting
- NCT04117672 — Antisecretory Factor In Severe Traumatic Brain Injury · Phase 2 · recruiting
- NCT04116138 — Antisecretory Factor in Primary Glioblastoma 1 · Phase 1, PHASE2 · completed
- NCT03453749 — Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury · Phase 2 · withdrawn
- NCT03339505 — Effect of Antisecretory Factor, Given as a Food Supplement to Adult Patients With Severe Traumatic Brain Injury · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06710249 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peter Siesjö
- Last refreshed: 22 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06710249.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing