Salovum® to lower tumor pressure, inflammation, and oxygen deficits in glioblastoma
Intratumoral Pressure, Intratumoral Partial Oxygen Pressure, and Inflammatory Cytokines in Antisecretory Factor Treatment of Glioblastoma
This trial will test whether taking Salovum®, an egg-yolk product containing antisecretory factor, can reduce pressure inside glioblastoma tumors, change inflammatory cytokine release, and affect tumor oxygen levels in adults having a diagnostic brain biopsy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Skane University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lund) |
| Trial ID | NCT07364786 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial implants probes during a standard diagnostic brain biopsy to measure intratumoral pressure, microdialysis for cytokines, and partial oxygen pressure. Participants ingest Salovum® starting 24–72 hours after the biopsy, and researchers compare measurements taken before and during Salovum® intake. The product is an egg yolk–derived preparation rich in antisecretory factor, previously shown to lower intracranial pressure in preclinical and some clinical head-injury contexts. The study focuses on short-term physiological effects on pressure, inflammation, oxygenation, and tumor volume rather than long-term clinical outcomes.
Who should consider this trial
Good fit: Adults aged 18–75 with suspected glioblastoma who are scheduled for a diagnostic biopsy and can give informed consent are the intended participants.
Not a fit: People with a known egg-yolk allergy or those not undergoing the biopsy and implant monitoring are unlikely to receive benefit from this intervention or the physiological measurements.
Why it matters
Potential benefit: If successful, Salovum® could lower tumor interstitial pressure and inflammation and improve oxygenation, which might make tumors more amenable to therapies or reduce local complications.
How similar studies have performed: Antisecretory factor preparations have reduced intracranial pressure and improved outcomes in animal models and some head-injury human data, but their use specifically in glioblastoma patients is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Suspected glioblastoma 2. Age 18-75 years 3. Planned diagnostic biopsy 4. Informed consent of subject Exclusion Criteria: 1\. Known egg yolk allergy
Where this trial is running
Lund
- Department of Neurosurgery, Skane University Hospital — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Peter Siesjö, MD, PhD — Skane University Hospital
- Study coordinator: Peter Siesjö, MD, PhD.
- Email: peter.siesjo@skane.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.