NCT05339230: SALFLADMET

A Randomized Phase 2 and Pilot Pharmacodynamic Trial Investigating the Effect of Salovum™ and SPC-flakes on Dihydropyrimidine Induced Gastrointestinal Toxicity and Tumour Perfusion in Colorectal Cancer

Status unknown NA Last updated 18 May 2022

What this trial tests

NA trial testing Salovum and SPC-flakes active or placebo in Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer in 73 participants. Status unknown.

Timeline

15 December 2020

Primary endpoint
1 December 2024

1 June 2025

Quick facts

Lead sponsor	Uppsala University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	73
Start date	15 December 2020
Primary completion	1 December 2024
Estimated completion	1 June 2025
Sites	1 location across Sweden

Drugs / interventions tested

• Salovum and SPC-flakes active or placebo

Conditions studied

• Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer — all drugs for Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer →

Sponsor

Uppsala University Hospital

Who can join

18 and older, any sex, with Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of diarrhoea CTCAEv5.0 ≥ grade 2.
  Time frame: During first 2 months of chemotherapy
  Chemotherapy induced toxicity to be counteracted by intervention

Sponsor's own description

One debilitating, and sometimes even life-threatening, toxicity from dihydropyrimidines, e g 5-FU and capecitabine, is gastrointestinal mucositis resulting in, eg severe diarrhoea necessitating in-hospital care including periods of support with iv fluids. The efficacy of current treatment for this adverse effect include iv fluids, loperamide and opioids po and octreotide sc is moderate and new treatment principles or, preferably, ways to prevent such toxicity, 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. 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". Another way to increase ASF and, thus, to achieve benefit, is to induce its production/ conversion 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 (SPC-flakes) as "Food for specific medical purposes".

Salovum has been shown to rapidly, ie within hours to a few days, antagonize diarrhoeal diseases of various etiologies. It has also been used against high fluid passages and inflammation in Crohns disease, Colitis ulcerosa and carcinoids in adults. SPC-flakes have similar effects but need weeks of administration to emerge. Interestingly from an oncological perspective, provision of exogenous ASF and induction of endogenous ASF has been shown to reduce interstitial fluid pressure (IFP) in tumours, increase tumour uptake of cytotoxic drugs and improve survival in animal tumour models.

With this background the present study will investigate if administration of ASF in the form of Salovum combined with induction of endogenous ASF by intake of SPC-flakes might be beneficial in colorectal cancer (CRC) patients to prevent dihydropyrimidine based chemotherapy induced gastrointestinal mucositis and to reduce tumor interstitial fluid pressure .

Publications & conference data

No peer-reviewed publications indexed yet for this trial.