NCT05669820

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Jan 2024Dec 2027

First Submitted

Initial submission to the registry

December 20, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 3, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 9, 2026

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

December 20, 2022

Last Update Submit

January 7, 2026

Conditions

Glioblastoma

Keywords

Antisecretory factorTrials, Randomized Clinical

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Survival

    up to 12 months from primary surgery

Secondary Outcomes (1)

  • Progress free survival at 6 and 12 months

    At 6 and 12 months from primary surgery

Other Outcomes (5)

  • Cognitive function

    up to 1 year

  • Neurological function

    up to 1 year

  • QOL Assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30

    up to 1 years

  • +2 more other outcomes

Study Arms (2)

Salovum

ACTIVE COMPARATOR

Salovum, an egg yolk powder will be orally at dose of 11 g 3 times daily.

Dietary Supplement: Salovum

Placebo

PLACEBO COMPARATOR

Placebo, an egg yolk powder will be orally at dose of 11 g 3 times daily.

Dietary Supplement: Placebo egg yolk powder

Interventions

SalovumDIETARY_SUPPLEMENT

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

Also known as: Antisecretory factor
Salovum
Placebo egg yolk powderDIETARY_SUPPLEMENT

Egg yolk powder derived from hen fed with normal feed.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Lund, 22185, Sweden

RECRUITING

Related Publications (1)

  • Ehinger E, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Kinhult S, Rydelius A, Nilsson C, Belting M, Bengzon J, Siesjo P. Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype: study protocol for a randomized double-blind placebo-controlled trial. Trials. 2025 Mar 13;26(1):86. doi: 10.1186/s13063-025-08792-z.

    PMID: 40083039DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

antisecretory factor

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Charlotte Edwardsson

    Skane University Hospital

    STUDY CHAIR

  • Erik Ehinger, MD

    Skane University Hospital

    STUDY CHAIR

Central Study Contacts

Peter Siesjö, MD, PhD

CONTACT

+4646171274peter.siesjo@med.lu.se

Johan Bengzon, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Eggyolk powder with same smell, texture and colour in identical packages.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, prospective, double blinded
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 3, 2023

Study Start

January 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 9, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

The datasets used and analysed in the current trial will be available in anonymized form after completion of the study, on reasonable request.

Locations

SE(1)