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

Condition(s) studied

Investigational drug(s) / intervention(s)

Salovum: Ingestion of Salovum 11g three times daily during 48 hours

Study 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.

Eligibility

Primary outcome measure(s)

• Intratumoral pressure after ingestion of Salovum® — 0 to 72 hours after diagnostic biopsy
  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.

Trial sites (1)

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