Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Substance Related Disorders

Breast Neoplasms

Diarrhea

Drug-Related Side Effects and Adverse Reactions

Breast Diseases

Skin Diseases

Signs and Symptoms, Digestive

Chemically-Induced Disorders

Gastrointestinal Agents

All Drugs and Chemicals

Antisecretory factor

Salovum egg powder high in antisecretory factor, 4 g/sachet. Four sachets, ie 16 gr q 8 hours for 6 days before start of abemaciclib

SPC-flakes flat dose 75gr/day in parallel and during first 12 weeks of treatment with abemaciclib

Placebo, identical to investigational product but without antisecretory factor.

SPC-flakes

Salovum

Placebo

Maria Larsson

Andreas Nearchou, MD

Greger Nilsson, MD, PhD

Olga Del Val Muñoz, MD

Anna-Karin Wennstig, MD, PhD

Henrik Lindman, MD, PhD

Cecilia Nilsson, MD, PhD

Antonis Valachis, MD, PhD

The present study aims to investigate a proactive strategy including Salovum™ and SPC-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer.

In patients with high-risk luminal breast cancer, the addition of CDK 4/6-inhibitor abemaciclib to adjuvant endocrine therapy for two years has been associated with improved disease-free survival and is now recommended from national and international guidelines as the preferred treatment strategy for this patient group. However, patients treated with abemaciclib have higher risk of diarrhea which primarily occurs during the first three months from treatment initiation and seems to impact patients' quality of life. As a result, early and proactive strategies to reduce the occurrence of diarrhea from the initiation of abemaciclib should be investigated to ensure that patients in whom adjuvant abemaciclib is recommended can complete their treatment as planned.

Randomization 1:1 to investigational product or placebo

Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer

A Randomized Double-blind Placebo Controlled Phase 3 Trial on the Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer - the ASF-BC Study

● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).

Occurrence of any-grade diarrhea according to CTCAE v. 5.0

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, besides diarrhea.

Rate of patients that stop or interrupt treatment with Salovum and SPC-flakes/placebo during planned study time.

Rate of patients that stop or interrupt treatment with abemaciclib during the planned treatment time of two years.

Henrik Lindman

Coordinating Investigator

Nervous System Diseases

Rare Diseases

Glioblastoma

Edema

Brain Edema

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Loperamide

Antidiarrheals

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

Egg yolk powder enriched for anti secretory factor

Peter Siesjö, MD, PhD

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.

Glioblastoma (GBM) 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 encompassing antisecretory and anti-inflammatory effect. 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.

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.

In a mouse model of malignant brain tumor, preliminary findings show that intratumoral infusion of AF-16 greatly enhances the effect of simultaneous intratumoral temozolomide treatment (90% and 40% survival, respectively). AF-16 also has preliminarily significant immune modulatory effects on myeloid cells in vitro, but also effects on the secretion of immune modulatory agents from tumor cells. 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.

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.

The described study is a safety and feasibility study and if these criteria are fulfilled, will be followed by a randomised controlled trial.

Phase 1-2, open label, single arm, single center.

Antisecretory Factor in Primary Glioblastoma 1

Antisecretory Factor, Administered as an Enriched Egg Powder, Salovum®, as Supplementary Therapy for Primary Glioblastoma During Concomitant Radio-chemotherapy.

As there are only 5 patients in this study individual patient data without age and gender will be shared after publication

Number of participants with decreased cognitive function assessed by Mini Mental State Examination (MMSE)

Neurologic function assessed by Neurologic Assessment in Neuro-Oncology (NANO) scale. Minimum 0 (no deficits) and maximum 25 (maximum deficits)

Number of participants with decreased performance assessed by Eastern Oncology Cooperative Group (ECOG) scale. Minum 0 (normal function) and maximum 4 (maximum disability)

Number of participants with decreased quality of life assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 and brain cancer module (BN20) questionnaire

Treatment related adverse events as assessed by CTCAE v 5.0

Defined as completing prescribed full Salovum treatment

Blood levels of triglyceride and cholesterol above normal range or increased from baseline

Intake of oral corticosteroids assessed weekly during and after intervention.

Analysis of anti secretory factor-16 (AF-16) blood levels by enzyme linked immunoassay

Analysis of interleukin-6 (IL-6), interleukin- (IL-8), monocyte chemotactic protein-1 (MCP-1), macrophage inflammatory protein-1a (MIP-1a), macrophage inflammatory protein-1b (MIP-1b) by multiplex analysis

Region Skane

Lund University

Skane University Hospital

Lantmannen Medical AB

Peter Siesjö

Professor

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

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

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

Egg yolk powder derived from hen fed with normal feed.

Placebo egg yolk powder

Johan Bengzon, MD, PhD

Peter Siesjö, MD

Erik Ehinger, MD

Charlotte Edwardsson

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

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).

Eggyolk powder with same smell, texture and colour in identical packages.

Antisecretory Factor Glioblastoma Phase 2

Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study

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

Assessed by Montreal Cognitive Assessment (MoCA)

Assessed by Neurologic Assessment in Neuro-Oncology (NANO) scale

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

Assessed by brain cancer module (BN20) questionnaire

Assessed by Eastern Oncology Cooperative Group (ECOG) performance scale

Progress free survival as a compound assessment by a multidisciplinary conference (MDC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer	NCT06152471	Early-stage Bre... Diarrhea Adverse Drug Ev...	SPC-flakes Salovum Placebo	18 Years -	Uppsala University Hospital
Antisecretory Factor in Primary Glioblastoma 1	NCT04116138	Glioblastoma Cerebral Edema Chemotherapy Ef...	Salovum	18 Years - 69 Years	Skane University Hospital
Antisecretory Factor in Primary Glioblastoma 1	NCT04116138	Glioblastoma Cerebral Edema Chemotherapy Ef...	Salovum	18 Years - 69 Years	Skane University Hospital
Antisecretory Factor in Primary Glioblastoma 1	NCT04116138	Glioblastoma Cerebral Edema Chemotherapy Ef...	Salovum	18 Years - 69 Years	Skane University Hospital
Antisecretory Factor Glioblastoma Phase 2	NCT05669820	Glioblastoma	Salovum Placebo egg yol...	18 Years - 75 Years	Skane University Hospital

Spots Global Cancer Trial Database for salovum

Every month we try and update this database with for salovum cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for salovum

Every month we try and update this database with for salovum cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for salovum cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.