Role of Antisecretory Factor in Curative Radiochemotherapy for Anal Carcinoma

NCT05351931 | Unknown

• 1 other identifier: ASF 3
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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, 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

Anal Cancer

Keywords

Radiochemotherapy; Adverse event; Antisecretory factor

Outcome Measures

Primary Outcomes (1)

• Incidence of diarrhoea, fecal urgency, anal skin toxicity/mucositis and anal pain CTCAEv5.0 ≥ grade 2 during and up to 6 months after RCT. Anal skin toxicity/mucositis is to be verified by photos.

  Treatment related toxicity

  Through study completion, approximately 6 months

Secondary Outcomes (7)

• Incidence and severity of other AEs according to CTCAEv5.0 during and up to 6 months after RCT.

  Through study completion, approximately 6 months

• Change from baseline in patient reported hQoL and abdominal symptoms assessed by EORTC QLQ- 30 and the ANL27 subscale questionnaires as well as the Bristol Stool Form Scale.

  Through study completion, approximately 6 months

• Increase in plasma (P)-ASF concentration from baseline to the day of start of RCT and to the end of treatment.

  Days -1, 6 and 42

• Relationships between P-ASF concentration, biomarkers reflecting inflammation and adverse events.

  Through study completion, approximately 6 months

• Differences in primary and secondary endpoints between Salovum and placebo subgroups.

  Through study completion, approximately 6 months

Other Outcomes (1)

• Incidence of AEs CTCAEv5.0 grade ≥ 2 considered probably related to investigational products/placebo.

  Through study completion, approximately 6 months

Study Arms (2)

SPC-flakes with or without Salovum

ACTIVE COMPARATOR

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.

Dietary Supplement: Salovum and SPC-flakes or corresponding placebo

SPC-flakes placebo with or without Salovum placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Salovum and SPC-flakes or corresponding placebo

Interventions

Salovum and SPC-flakes or corresponding placebo DIETARY_SUPPLEMENT

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

SPC-flakes placebo with or without Salovum placebo; SPC-flakes with or without Salovum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically confirmed diagnosis of AC irrespective of tumour p16-status.
• Planned for curative RCT according to national care programme schedule B
• WHO performance status of 0 or 1.
• For patients planned for schedule C, they must be unsuitable for or not consenting to participation in the SWANCA trial.
• Able to understand study information and questionnaires and provide signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Lantmännen AB: collaborator
• Sjöbergstiftelsen: collaborator
• Onkologiska klinikens forskningsfond: collaborator
• Swedish Cancer Society: collaborator

Related Publications (6)

• Cinausero 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 BACKGROUND

• Ulgheri 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 BACKGROUND

• Johansson 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 BACKGROUND

• Lonnroth 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 BACKGROUND

• Laurenius 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 BACKGROUND

• Eriksson 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 BACKGROUND

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Central Study Contacts

Peter Nygren, MD

CONTACT

+46704250719; peter.nygren@igp.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo similar to active study products
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant in oncology

Model Details: Randomized parallel two groups

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 28, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share