Antisecretory Factor Glioblastoma Phase 2

NCT ID: NCT05669820

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-12-01

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

Detailed Description

Glioblastoma (GB) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%. AF is a 41kilodalton endogenous and essential protein with antisecretory and anti-inflammatory effects. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union an din other countries.

Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.

AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.

Intratumoral delivery of AF-16 potentiated the effect of intratumoral temozolomide in an experimental model of glioblastoma.

Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.

Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.

In a completed phase1-2 trial in participants with primary gliobalstoma the add on of Salovum during concomitant radiochemotherapa was considered safe and feasible.

The current study is aimed at assessing the efficacy of Salovum in a RCT (randomised controlled trail).

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Salovum

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

Group Type: ACTIVE_COMPARATOR

Salovum

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo egg yolk powder

Intervention Type: DIETARY_SUPPLEMENT

Egg yolk powder derived from hen fed with normal feed.

Interventions

Salovum

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo egg yolk powder

Egg yolk powder derived from hen fed with normal feed.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Antisecretory factor

Eligibility Criteria

Inclusion Criteria

1. Pathology verified glioblastoma or astrocytoma grade 4

2. Age 18-75 years

3. Surgical treatment-resection.

4. Scheduled concomitant radiochemotherapy, or only chemotherapy.

5. Informed consent

Exclusion Criteria

1. No informed consent

2. Egg yolk allergy

3. Only surgical biopsy

4. Only radiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Peter Siesjö

OTHER

Sponsor Role: lead

Responsible Party

Peter Siesjö

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charlotte Edwardsson

Role: STUDY_CHAIR

Skane University Hospital

Erik Ehinger, MD

Role: STUDY_CHAIR

Skane University Hospital

Locations

Skåne University Hospital

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Peter Siesjö, MD, PhD

Role: CONTACT

peter.siesjo@med.lu.se

+4646171274

Johan Bengzon, MD, PhD

Role: CONTACT

Facility Contacts

Peter Siesjö, MD

Role: primary

peter.siesjo@med.lu.se

+46705655778

Erik Ehinger, MD

Role: backup

erik.ehinger@med.lu.se

+46707970783

References

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.

Reference Type: DERIVED

PMID: 40083039 (View on PubMed)

Other Identifiers

FPAFGB2ver6

Identifier Type: -

Identifier Source: org_study_id