Clinical trial · Interventional

Role of Antisecretory Factor in Curative Radiochemotherapy for Anal Carcinoma

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

NCT05351931CI-TRIAL-00058111SALFLACunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

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
Anal Cancer	Malignant Anal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Salovum and SPC-flakes or corresponding placebo	Dietary Supplement	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
SPC-flakes with or without Salovum
description
SPC-flakes flat dose of 75 g/d divided in 2 - 4 doses started 5 days prior to start of RCT and continued during the RCT. Salovum egg powder 4 g/sachet. Four sachets, ie 16 g q 8 h for 5 days prior to start of RCT. The appropriate amount of Salovum is mixed with 100 - 200 ml of suitable liquid, eg fruit juice, and ingested orally.
interventionNames
1. Dietary Supplement: Salovum and SPC-flakes or corresponding placebo
type
PLACEBO_COMPARATOR
label
SPC-flakes placebo with or without Salovum placebo
description
SPC-placebo flat dose of 75 g/d divided in 2 - 4 doses started 5 days prior to start of RCT and continued during the RCT. Salovum placebo egg powder 4 g/sachet. Four sachets, ie 16 g q 8 h for 5 days prior to start of RCT. The appropriate amount of Salovum placebo is mixed with 100 - 200 ml of suitable liquid, eg fruit juice, and ingested orally.
interventionNames
1. Dietary Supplement: Salovum and SPC-flakes or corresponding placebo

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 AC irrespective of tumour p16-status.
3. Planned for curative RCT according to national care programme schedule B
4. WHO performance status of 0 or 1.
5. For patients planned for schedule C, they must be unsuitable for or not consenting to participation in the SWANCA trial.
6. Able to understand study information and questionnaires and provide signed informed consent.

Exclusion Criteria:

1. Patients with stoma.
2. 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.
3. Contraindications to curative RCT in accordance with AC national care programme.
4. Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator.
5. Prior exposure to Salovum or SPC-flakes.

References

Publications (6)

BACKGROUNDCinausero M, Aprile G, Ermacora P, Basile D, Vitale MG, Fanotto V, Parisi G, Calvetti L, Sonis ST. New Frontiers in the Pathobiology and Treatment of Cancer Regimen-Related Mucosal Injury. Front Pharmacol. 2017 Jun 8;8:354. doi: 10.3389/fphar.2017.00354. eCollection 2017. PMID 28642709
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
BACKGROUNDLonnroth I, Lange S. Purification and characterization of the antisecretory factor: a protein in the central nervous system and in the gut which inhibits intestinal hypersecretion induced by cholera toxin. Biochim Biophys Acta. 1986 Aug 6;883(1):138-44. doi: 10.1016/0304-4165(86)90144-3. PMID 3524692
BACKGROUNDLaurenius A, Wangberg B, Lange S, Jennische E, Lundgren BK, Bosaeus I. Antisecretory factor counteracts secretory diarrhoea of endocrine origin. Clin Nutr. 2003 Dec;22(6):549-52. doi: 10.1016/s0261-5614(03)00057-8. PMID 14613757
BACKGROUNDEriksson A, Shafazand M, Jennische E, Lange S. Effect of antisecretory factor in ulcerative colitis on histological and laborative outcome: a short period clinical trial. Scand J Gastroenterol. 2003 Oct;38(10):1045-9. doi: 10.1080/00365520310005064. PMID 14621278