Actively Recruiting

Phase 2
Age: 18Years - 79Years
All Genders
ID06710249

Impact of Salovum and SPC Flakes on Cerebral Edema Caused by Brain Tumors

Led by Peter Siesjö · Updated on 2025-01-27

20

Participants Needed

1

Research Sites

109 weeks

Total Duration

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Sponsors

P

Peter Siesjö

Lead Sponsor

L

Lund University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effects of Salovum4, an egg yolk powder rich in the antisecretory factor protein, and SPC4 flakes, specially processed oats, on cerebral edema and its symptoms in people with brain tumors like glioblastoma, cerebral metastases, and meningioma. The study aims to see if these dietary supplements can improve clinical symptoms caused by tumor-related brain swelling and reduce the swelling seen on MRI scans. It also examines the impact on patients with steroid-resistant and steroid-nave cerebral edema. Participants will take Salovum4, 11 grams three times daily for 14 days, then gradually reduce the dose over the next 14 days. Starting on day 7, they will also consume SPC4 flakes daily at 1 gram per kilogram of body weight. Patients with steroid-nave edema will be monitored daily as inpatients, and if no improvement occurs within 3 days, steroids will be started. Those with steroid-refractory edema will be evaluated after 7 days, with steroids adjusted if needed. MRI scans will assess edema changes at baseline and again at 14 or 28 days depending on steroid use. During the study, participants will be evaluated using neurological and cognitive scales, including the NANO scale for neurological symptoms, MOCA for cognitive function, and ECOG for performance status. MRI scans will measure edema volume and index. Researchers will track steroid medication doses and analyze changes over time to determine any effects of the interventions. The total involvement includes initial evaluation, 28 days of treatment and tapering, and follow-up assessments to ensure safety and measure outcomes.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 79 years
  • Known or suspected primary or secondary brain tumor with surrounding edema causing clinical signs
  • Glasgow Coma Scale (GCS) between 14 and 15
  • WHO ECOG performance status 0 to 2
  • Planned or started cortisone treatment
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Allergy to egg yolk
  • Midline brain shift greater than 5 mm
  • Glasgow Coma Scale (GCS) 13 or lower
  • Epilepsy as the only symptom from the cerebral edema

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Neurosurgery

Lund, Sweden, 22185

Actively Recruiting

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Research Team

P

Peter Siesjö, MD, PhD

E

Erik Ehinger, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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