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Trial Title:
Antisecretory Factor Glioblastoma Phase 2
NCT ID:
NCT05669820
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Antisecretory factor
Conditions: Keywords:
Antisecretory factor
Trials, Randomized Clinical
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, prospective, double blinded
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Eggyolk powder with same smell, texture and colour in identical packages.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Salovum
Description:
Salovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals)
and contains increased amounts of the endogenous protein antisecretory factor.
Arm group label:
Salovum
Other name:
Antisecretory factor
Intervention type:
Dietary Supplement
Intervention name:
Placebo egg yolk powder
Description:
Egg yolk powder derived from hen fed with normal feed.
Arm group label:
Placebo
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Skåne University Hospital
Address:
City:
Lund
Zip:
22185
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Peter Siesjö, MD
Phone:
+46705655778
Email:
peter.siesjo@med.lu.se
Contact backup:
Last name:
Erik Ehinger, MD
Phone:
+46707970783
Email:
erik.ehinger@med.lu.se
Start date:
January 15, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Peter Siesjö
Agency class:
Other
Collaborator:
Agency:
Lund University
Agency class:
Other
Source:
Skane University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05669820
