Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05351931
Status:
UNKNOWN
Last Update Posted:
2022-04-28
First Post:
2022-04-14
Brief Title:
Role of Antisecretory Factor in Curative Radiochemotherapy for Anal Carcinoma
Sponsor:
Uppsala University Hospital
Organization:
Uppsala University Hospital
Study Overview
Official Title:
A Randomized Phase 2 Double-blind Placebo-controlled Trial Investigating the Effect of Salovum and SPC-flakes on Radiochemotherapy Induced Toxicity in Curative Treatment of Anal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SALFLAC
Brief Summary:
Curative radiochemotherapy RCT for anal carcinoma AC is associated with considerable acute and long-term toxicity The acute toxicity derives from the combined effects of radiation and chemotherapy and is dominated by localized skin mucositis diarrhoea and pain from radiation and nausea fatigue anemialeukopenia diarrhoea and general skin dryness from chemotherapy Cholera induced diarrhoea as well as other forms of diarrhoea-inducing agents has been shown to elicit a stimulated endogenous production of a protein named antisecretory factor ASF This protein has been chemically characterized in detail ASF acts by modulating secretion of water and ions but also counteracts inflammatory processes With this background the present study will investigate if induction of endogenous ASF by intake of SPC-flakes might be beneficial in AC patients to prevent RCT induced adverse events AEs and if administration of ASF from Salovum provides additional benefit explorative
Detailed Description:
Curative RCT for AC is associated with considerable acute and long-term toxicity
The acute toxicity derives from the combined effects of radiation and chemotherapy and is dominated by localized skin mucositis diarrhoea and pain from radiation and nausea fatigue anemialeukopenia diarrhoea and general skin dryness from chemotherapy These adverse effects are treated symptomatically with mostly modest effect and sometimes leads to the need for in-patient care and temporary stop of the RCT Long-term toxicity is caused by radiation fibrosis and is dominated by impaired anal sphincter function leading to faeces incontinence pelvic pain and reduced sexual function Thus new ways to efficiently counteract the RCT induced adverse effects are urgently needed
Cholera induced diarrhoea as well as other forms of diarrhoea-inducing agents has been shown to elicit a stimulated endogenous production of a protein named antisecretory factor ASF This protein has been chemically characterized in detail ASF acts by modulating secretion of water and ions but also counteracts inflammatory processes ASF is also produced by hens fed on a diet of fermented grains or a specific diet of sugars and amino acids leading to an accumulation of the ASF protein in the egg yolk Spray dried yolk in the form of a powder is commercialized as Salovum registered by the EU authorities as Food for specific medical purposes i e is not adrug from a regulatory perspective
Salovum rapidly increase the plasma P- ASF-concentration Another way to increase ASF and thus to achieve benefit is to induce its productionconversion by ingestion of oat flakes specially processed similar to malting to contain the proper mix of sugars and amino acids Such flakes are also commercially available named SPC flakes as Food for specific medical purposes and has been recommended or considered for a number of secretory pathological conditions e g for treatment of Mb Meniére
With this background the present study will investigate if induction of endogenous ASF by intake of SPC-flakes might be beneficial in AC patients to prevent RCT induced adverse events AEs and if administration of ASF from Salovum provides additional benefit explorative
The acute toxicity derives from the combined effects of radiation and chemotherapy and is dominated by localized skin mucositis diarrhoea and pain from radiation and nausea fatigue anemialeukopenia diarrhoea and general skin dryness from chemotherapy These adverse effects are treated symptomatically with mostly modest effect and sometimes leads to the need for in-patient care and temporary stop of the RCT Long-term toxicity is caused by radiation fibrosis and is dominated by impaired anal sphincter function leading to faeces incontinence pelvic pain and reduced sexual function Thus new ways to efficiently counteract the RCT induced adverse effects are urgently needed
Cholera induced diarrhoea as well as other forms of diarrhoea-inducing agents has been shown to elicit a stimulated endogenous production of a protein named antisecretory factor ASF This protein has been chemically characterized in detail ASF acts by modulating secretion of water and ions but also counteracts inflammatory processes ASF is also produced by hens fed on a diet of fermented grains or a specific diet of sugars and amino acids leading to an accumulation of the ASF protein in the egg yolk Spray dried yolk in the form of a powder is commercialized as Salovum registered by the EU authorities as Food for specific medical purposes i e is not adrug from a regulatory perspective
Salovum rapidly increase the plasma P- ASF-concentration Another way to increase ASF and thus to achieve benefit is to induce its productionconversion by ingestion of oat flakes specially processed similar to malting to contain the proper mix of sugars and amino acids Such flakes are also commercially available named SPC flakes as Food for specific medical purposes and has been recommended or considered for a number of secretory pathological conditions e g for treatment of Mb Meniére
With this background the present study will investigate if induction of endogenous ASF by intake of SPC-flakes might be beneficial in AC patients to prevent RCT induced adverse events AEs and if administration of ASF from Salovum provides additional benefit explorative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None