Clinical trial · Interventional
Role of Antisecretory Factor in Dihydropyrimidine Treatment of Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salovum and SPC-flakes active or placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- description
- Salovum egg powder high in antisecretory factor, 4 g/sachet. Four sachets, ie 16 g q 8 h for 6 days starting 6 days before 1st cycle of chemotherapy. SPC-flakes flat dose of 75 g/d divided in 2 - 4 doses started in parallel with Salovum to be continued during the first 8 weeks of chemotherapy.
- interventionNames
- Dietary Supplement: Salovum and SPC-flakes active or placebo
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Salovum placebo powder without antisecretory factor, 4 g/sachet. Four sachets, ie 16 g q 8 h for 6 days starting 6 days before 1st cycle of chemotherapy. SPC placebo flakes flat dose of 75 g/d divided in 2 - 4 doses started in parallel with Salovum placebo to be continued during the first 8 weeks of chemotherapy.
- interventionNames
- Dietary Supplement: Salovum and SPC-flakes active or placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed diagnosis of colorectal cancer. 3. Planned to start 1st line dihydropyrimidine (i e 5-FU or capecitabine) based chemotherapy in the adjuvant, neoadjuvant or palliative setting. 4. Planned duration of chemotherapy ≥ 2 months. 5. Signed informed consent. 6. Liver metastatic disease (pharmacodynamics study only). Exclusion Criteria: 1. Contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol. 2. Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator. 3. Prior exposure to 5-FU based chemotherapy. 4. Prior exposure to Salovum or SPC-flakes.
References
Publications (6)
- BACKGROUNDUlgheri C, Paganini B, Rossi F. Antisecretory factor as a potential health-promoting molecule in man and animals. Nutr Res Rev. 2010 Dec;23(2):300-13. doi: 10.1017/S0954422410000193. Epub 2010 Aug 5. PMID 20684797
- BACKGROUNDJohansson E, Jennische E, Lange S, Lonnroth I. Antisecretory factor suppresses intestinal inflammation and hypersecretion. Gut. 1997 Nov;41(5):642-5. doi: 10.1136/gut.41.5.642. PMID 9414971
- BACKGROUNDZaman S, Aamir K, Lange S, Jennische E, Silfverdal SA, Hanson LA. Antisecretory factor effectively and safely stops childhood diarrhoea: a placebo-controlled, randomised study. Acta Paediatr. 2014 Jun;103(6):659-64. doi: 10.1111/apa.12581. Epub 2014 Mar 10. PMID 24484450
- BACKGROUNDBjorck S, Bosaeus I, Ek E, Jennische E, Lonnroth I, Johansson E, Lange S. Food induced stimulation of the antisecretory factor can improve symptoms in human inflammatory bowel disease: a study of a concept. Gut. 2000 Jun;46(6):824-9. doi: 10.1136/gut.46.6.824. PMID 10807895
- BACKGROUNDAl-Olama M, Wallgren A, Andersson B, Gatzinsky K, Hultborn R, Karlsson-Parra A, Lange S, Hansson HA, Jennische E. The peptide AF-16 decreases high interstitial fluid pressure in solid tumors. Acta Oncol. 2011 Oct;50(7):1098-104. doi: 10.3109/0284186X.2011.562240. Epub 2011 Mar 4. PMID 21375367
- BACKGROUNDIlkhanizadeh S, Sabelstrom H, Miroshnikova YA, Frantz A, Zhu W, Idilli A, Lakins JN, Schmidt C, Quigley DA, Fenster T, Yuan E, Trzeciak JR, Saxena S, Lindberg OR, Mouw JK, Burdick JA, Magnitsky S, Berger MS, Phillips JJ, Arosio D, Sun D, Weaver VM, Weiss WA, Persson AI. Antisecretory Factor-Mediated Inhibition of Cell Volume Dynamics Produces Antitumor Activity in Glioblastoma. Mol Cancer Res. 2018 May;16(5):777-790. doi: 10.1158/1541-7786.MCR-17-0413. Epub 2018 Feb 5. PMID 29431617