Effect of Salovum® on Pressure, Oxygen and Inflammation in Glioblastoma

NCT07364786 | Recruiting Phase 2

• 1 other identifier: AFGBMBiopsi.v7
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to investigate the effects of Salovum®, an egg yolk powder enriched with the endogenous protein antisecretory factor, in participants undergoing diagnostic biopsies for suspected glioblastoma. The primary questions the trial seeks to answer are:

• Will Salovum® reduce intratumoral pressure?
• Will Salovum® influence the release of inflammatory cytokines from tumor tissue? Additionally, the study will investigate the impact of Salovum® on intratumoral partial oxygen pressure and tumor volume. Researchers will:
• Place probes for measuring intratumoral pressure, microdialysis, and partial oxygen pressure during a standard biopsy procedure.
• Compare measurements from participants before and during ingestion of Salovum®. Participants will:
• Have probes implanted during a surgical biopsy.
• Ingest Salovum® 24 to 72 hours after the procedure.

Conditions

Glioblastoma

Keywords

Glioblastoma; interstitial fluid pressure; cytokine; diagnostic biopsy; partial oxygen pressure; antisecretory factor

Outcome Measures

Primary Outcomes (1)

• Intratumoral pressure after ingestion of Salovum®

  To measure intratumoral pressure by insertion of catheters to measure pressure (Sophysa, France) before and during ingestion of Salovum® in participants diagnosed with glioblastoma (GBM) who undergo a diagnostic biopsy.

  0 to 72 hours after diagnostic biopsy

Secondary Outcomes (1)

• Inflammatory cytokine release after ingestion of Salovum®

  0 to 72 hours after diagnostic biopsy

Other Outcomes (4)

• Intratumoral partial oxygen pressure after ingestion of Salovum®

  0 to 72 hours after diagnostic biopsy

• Tumor volume after ingestion of Salovum®

  At time of standard follow up MRI 3-4 months after a diagnostic biopsy

• Intratumoral pressure versus intracerebral pressure

  0-72 hours

Study Arms (1)

Salovum

EXPERIMENTAL

Ingestion of Salovum during 48 hours starting 24 hours after diagnostic biopsy

Dietary Supplement: Salovum

Interventions

Salovum DIETARY_SUPPLEMENT

Ingestion of Salovum 11g three times daily during 48 hours

Also known as: Antisecretory factor

Salovum

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected glioblastoma
• Age 18-75 years
• Planned diagnostic biopsy
• Informed consent of subject

You may not qualify if:

• \. Known egg yolk allergy

Sponsors & Collaborators

• Peter Siesjö: lead
• Lund University: collaborator
• Region Skane: collaborator

Study Sites (1)

Department of Neurosurgery, Skane University Hospital

Lund, 221 85, Sweden

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

antisecretory factor

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Peter Siesjö, MD, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Siesjö, MD, PhD.

CONTACT

+46705655778; peter.siesjo@skane.se

Erik Ehinger, MD

CONTACT

46707970783; erik.ehinger@med.lu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Consultant Neurosurgeon

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: January 23, 2026
• Study Start: October 7, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

SE (1)