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Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype : study protocol for a randomized double-blind placebo-controlled trial

Ehinger, Erik LU ; Darabi, Anna LU ; Visse, Edward LU ; Edvardsson, Charlotte LU ; Tomasevic, Gregor LU ; Cederberg, David LU ; Kinhult, Sara LU ; Rydelius, Anna LU ; Nilsson, Christer LU and Belting, Mattias LU , et al. (2025) In Trials 26(1).
Abstract

Background: Glioblastoma, IDH wildtype is the most common primary malignant brain tumor in adults. Despite best available treatment, prognosis remains poor. Current standard therapy consists of surgical tumor removal followed by radiotherapy and chemotherapy with the alkylating agent temozolomide. Antisecretory factor (AF), an endogenous protein, may potentiate the effect of temozolomide and alleviate cerebral edema. Salovum® is an egg-yolk powder enriched for AF and is classified as a medical food in the European Union. Salovum® has shown preliminary clinical effect on glioblastoma in a recent pilot study. Here, we aim to assess if add-on Salovum® to temozolomide therapy can improve outcomes in patients with newly diagnosed... (More)

Background: Glioblastoma, IDH wildtype is the most common primary malignant brain tumor in adults. Despite best available treatment, prognosis remains poor. Current standard therapy consists of surgical tumor removal followed by radiotherapy and chemotherapy with the alkylating agent temozolomide. Antisecretory factor (AF), an endogenous protein, may potentiate the effect of temozolomide and alleviate cerebral edema. Salovum® is an egg-yolk powder enriched for AF and is classified as a medical food in the European Union. Salovum® has shown preliminary clinical effect on glioblastoma in a recent pilot study. Here, we aim to assess if add-on Salovum® to temozolomide therapy can improve outcomes in patients with newly diagnosed glioblastoma. Methods: This is a multi-center, double-blinded, randomized, placebo-controlled phase II-III clinical trial to investigate superiority of Salovum® over placebo as add-on treatment for glioblastoma during concomitant and adjuvant temozolomide therapy. Patients with newly diagnosed glioblastoma that are planned for temozolomide treatment are screened for eligibility and randomized to receive Salovum® (n = 150) or placebo (n = 150). An interim analysis will be performed after 80 included patients to guide whether to continue or terminate. Primary endpoint is 12-month overall survival. Secondary outcome is 24-month overall survival. Discussion: This study will likely produce high-grade evidence to support or reject Salovum® as add-on treatment for glioblastoma. Trial registration: ClinicalTrials.gov NCT05669820. Registered on January 3, 2023.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Antisecretory factor, Glioblastoma, Glioblastoma, IDH wildtype, Newly diagnosed, Protocol, Randomized clinical trial, Salovum
in
Trials
volume
26
issue
1
article number
86
publisher
BioMed Central (BMC)
external identifiers
  • pmid:40083039
  • scopus:105000302407
ISSN
1745-6215
DOI
10.1186/s13063-025-08792-z
language
English
LU publication?
yes
id
150dfb45-94ce-4a8f-b776-5ca5b437a692
date added to LUP
2025-12-19 14:31:23
date last changed
2025-12-20 03:00:08
@article{150dfb45-94ce-4a8f-b776-5ca5b437a692,
  abstract     = {{<p>Background: Glioblastoma, IDH wildtype is the most common primary malignant brain tumor in adults. Despite best available treatment, prognosis remains poor. Current standard therapy consists of surgical tumor removal followed by radiotherapy and chemotherapy with the alkylating agent temozolomide. Antisecretory factor (AF), an endogenous protein, may potentiate the effect of temozolomide and alleviate cerebral edema. Salovum® is an egg-yolk powder enriched for AF and is classified as a medical food in the European Union. Salovum® has shown preliminary clinical effect on glioblastoma in a recent pilot study. Here, we aim to assess if add-on Salovum® to temozolomide therapy can improve outcomes in patients with newly diagnosed glioblastoma. Methods: This is a multi-center, double-blinded, randomized, placebo-controlled phase II-III clinical trial to investigate superiority of Salovum® over placebo as add-on treatment for glioblastoma during concomitant and adjuvant temozolomide therapy. Patients with newly diagnosed glioblastoma that are planned for temozolomide treatment are screened for eligibility and randomized to receive Salovum® (n = 150) or placebo (n = 150). An interim analysis will be performed after 80 included patients to guide whether to continue or terminate. Primary endpoint is 12-month overall survival. Secondary outcome is 24-month overall survival. Discussion: This study will likely produce high-grade evidence to support or reject Salovum® as add-on treatment for glioblastoma. Trial registration: ClinicalTrials.gov NCT05669820. Registered on January 3, 2023.</p>}},
  author       = {{Ehinger, Erik and Darabi, Anna and Visse, Edward and Edvardsson, Charlotte and Tomasevic, Gregor and Cederberg, David and Kinhult, Sara and Rydelius, Anna and Nilsson, Christer and Belting, Mattias and Bengzon, Johan and Siesjö, Peter}},
  issn         = {{1745-6215}},
  keywords     = {{Antisecretory factor; Glioblastoma; Glioblastoma, IDH wildtype; Newly diagnosed; Protocol; Randomized clinical trial; Salovum}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype : study protocol for a randomized double-blind placebo-controlled trial}},
  url          = {{http://dx.doi.org/10.1186/s13063-025-08792-z}},
  doi          = {{10.1186/s13063-025-08792-z}},
  volume       = {{26}},
  year         = {{2025}},
}