Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema

Condition(s) studied

Investigational drug(s) / intervention(s)

Salovum/SPC flakes: Egg yolk powder and specially processed cereals

Study 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

Primary outcome measure(s)

• Change of neurological symptoms — 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)

Trial sites (1)

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