RecruitingPhase 2Phase 3NCT05669820

Antisecretory Factor Glioblastoma Phase 2

Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study

Sponsor

Peter Siesjö

Enrollment

300 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

Summary

This is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days after finalisation plus during adjuvant chemotherapy.The primary aims of are overall survival at 6 and 12 months after diagnosis

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests antisecretory factor (AF) — a naturally occurring protein found in egg yolk — as a treatment to reduce brain swelling in patients with glioblastoma or grade 4 astrocytoma, aggressive brain tumors. AF is being studied as an add-on to standard treatment. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with glioblastoma or grade 4 astrocytoma confirmed by tissue analysis - You have had surgical tumor removal (resection) - You are scheduled to receive chemotherapy with or without radiation therapy **You may NOT be eligible if...** - You have an allergy to egg yolk - You have only had a biopsy (not full surgical removal) - You are only receiving radiation therapy without chemotherapy - You are unable or unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSalovum

Salovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals) and contains increased amounts of the endogenous protein antisecretory factor.

DIETARY_SUPPLEMENTPlacebo egg yolk powder

Egg yolk powder derived from hen fed with normal feed.