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

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

Inclusion Criteria5

  • Pathology verified glioblastoma or astrocytoma grade 4
  • Age 18-75 years
  • Surgical treatment-resection.
  • Scheduled concomitant radiochemotherapy, or only chemotherapy.
  • Informed consent

Exclusion Criteria4

  • No informed consent
  • Egg yolk allergy
  • Only surgical biopsy
  • Only radiotherapy

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.


Locations(1)

Skåne University Hospital

Lund, Sweden

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NCT05669820


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