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Role of Antisecretory Factor in Curative Radiochemotherapy for Anal Carcinoma

NCT05351931 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-04-28

No results posted yet for this study

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, anemia/leukopenia, 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).

Conditions

Interventions

DIETARY_SUPPLEMENT

Salovum and SPC-flakes or corresponding placebo

Salovum and SPC-flakes are foods approved for specific medical purposes.

Sponsors & Collaborators

  • Lantmännen AB

    collaborator UNKNOWN

  • Sjöbergstiftelsen

    collaborator UNKNOWN

  • Onkologiska klinikens forskningsfond

    collaborator UNKNOWN

  • Swedish Cancer Society

    collaborator OTHER

  • Uppsala University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-12-31
Completion
2024-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351931 on ClinicalTrials.gov