Antisecretory Factor in Primary Glioblastoma 1

NCT04116138 | Completed Phase 1

• 1 other identifier: AFGBM1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.

Conditions

Glioblastoma; Cerebral Edema; Chemotherapy Effect

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse

  Treatment related adverse events as assessed by CTCAE v 5.0

  Cumulative from day 1 to 80

• Number of participants with completion of prescribed Salovum treatment

  Defined as completing prescribed full Salovum treatment

  Cumulative from day 1 to 80

Secondary Outcomes (4)

• Number of participants with altered blood levels of triglycerides and cholesterol

  Change from baseline at day 20, 57 and 70.

• Number of participants with reduced or no steroid intake

  Change from baseline at day 7, 14, 21, 28, 35, 42, 49, 56, 63 and 70.

• Number of participants with detetable blood levels antisecretory factor

  Change from baseline at day 20, 57 and 70.

• Number of participants with altered blood levels of inflammatory cytokines

  Change from baseline at day 20, 57 and 70.

Other Outcomes (4)

• Cognitive function

  Change from baseline at day 20, 57 and 70.

• Number of participants with decreased neurological function

  Change from baseline at day 20, 57 and 70.

• Number of participants with decreased performance

  Change from baseline at day 20, 57 and 70.

Study Arms (1)

Salovum

EXPERIMENTAL

Salovum®, an egg powder enriched for anti secretory factor.

Dietary Supplement: Salovum

Interventions

Salovum DIETARY_SUPPLEMENT

Egg yolk powder enriched for anti secretory factor

Also known as: Antisecretory factor

Salovum

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology verified glioblastoma
• Age 18-69 years
• Surgical treatment-biopsy or resection.
• Scheduled full concomitant radiochemotherapy treatment with radiation (60 Gy) and temozolomide,
• Informed consent

You may not qualify if:

• No informed consent
• Egg yolk allergy

Sponsors & Collaborators

• Peter Siesjö: lead
• Region Skane: collaborator
• Lund University: collaborator
• Skane University Hospital: collaborator
• Lantmannen Medical AB: collaborator

Study Sites (1)

Department of Neurosurgery

Lund, 22185, Sweden

Location

Related Publications (1)

• Ehinger E, Kopecky J, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Belting M, Bengzon J, Siesjo P. Antisecretory factor is safe to use as add-on treatment in newly diagnosed glioblastoma. BMC Neurol. 2023 Feb 18;23(1):76. doi: 10.1186/s12883-023-03119-4.

  PMID: 36803465 DERIVED

MeSH Terms

Conditions

Glioblastoma; Brain Edema

Interventions

antisecretory factor

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Peter Siesjö, MD, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Phase 1-2, open label, single arm, single center.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 4, 2019
• Study Start: September 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De identified individual patient data will be made available from 3 months after publication up to 24 months after publication
• Access Criteria: By request from researcher

Locations

SE (1)