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Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy (LOWOL)

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Plenvu

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Bowel Preparation Solutions, Screening colonoscopy, Adenoma detection rate, Tolerability, 1L PEG plus ascorbate, Magnesium citrate plus picosulphate

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged 50 to 69 years who have participated in the early detection programme for colon and rectal cancer (PDPCCR) in Barcelona, who have obtained a positive result in the faecal occult blood test (≥20 μg Hb/g faeces) and who are scheduled for a screening colonoscopy at Hospital Clínic de Barcelona.

Exclusion Criteria:

People who do not agree to participate in the study.
People with known severe renal failure (grade IV or V) and grade III and IV heart failure according to the New York Heart Association (NYHA) Scale of Functional Assessment of Heart Failure
Individuals who have undergone a colonoscopy in the past year.
Subjects meeting the Rome IV Criteria for the diagnosis of functional constipation
Subjects with mental disabilities or with a severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders).
Individuals who do not understand Catalan or Spanish verbally and in writing.
Individuals with partial or total colon resection.
Individuals with a personal history of CRC or colorectal disease amenable to specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
Individuals with terminal illness or severe illness/disability that contraindicates further study of the colon.
People with gastrointestinal disorders that contraindicate the use of the study products (gastric emptying disorders, perforation or gastrointestinal obstruction, ileus, toxic megacolon).
People with congestive heart failure
Hypermagnesemia
Rhabdomyolysis
Phenylketourine
Glucose-6-phosphate dehydrogenase deficiency
People with hypersensitivity to the active ingredients of excipients
People with severe renal impairment

Sites / Locations

Hospital CLinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plenvu

Citrafleet

Arm Description

Plenvu split dose

citrafleet in split dose

Outcomes

Primary Outcome Measures

Adenoma detection rate

The percentage of patients with at least one adenoma in relation to the total subjects in each group of study

Secondary Outcome Measures

Colonoscopy quality

Colonoscopy quality is assess with Boston Bowel Preparation Scale (BBPS) in which each colon segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). It will be considered adequate when each segment is scored ≥2.

Lesion detection rate

The percentage of patients with at least one polyp in relation to the total subjects in each group

Caecal intubation rate

If the caecum has been reached in the colonoscopy, it will be considered complete; otherwise, it will be considered incomplete

Rate of adverse events related to the administration of the preparation

Evaluated with the Tolerability and Satisfaction Questionnaire including symptoms such as nausea, vomiting, abdominal pain, bloating, headache, chills, dizziness, and dry mouth

Tolerability and satisfaction with preparation

Assessed by completing a tolerability and satisfaction questionnaire that has been prepared from the validated questionnaire Mayo Clinic Bowel Prep Tolerability Questionnaire (Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep; 46(9):808-12.doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19. PubMed PMID: 24953203) and which has been adapted and translated into Spanish

Full Information

NCT ID

NCT04297423

First Posted

March 4, 2020

Last Updated

September 6, 2022

Sponsor

Hospital Clinic of Barcelona

Collaborators

Casen Recordati S.L., Fundacion Clinic per a la Recerca Biomédica

1. Study Identification

Unique Protocol Identification Number

NCT04297423

Brief Title

Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy

Acronym

LOWOL

Official Title

Eficacia y Tolerabilidad de Dos Productos de Volumen Reducido Para la Colonoscopia de Cribado: Ensayo Comparativo Paralelo Aleatorizado

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 11, 2020 (Actual)

Primary Completion Date

June 28, 2022 (Actual)

Study Completion Date

June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

Collaborators

Casen Recordati S.L., Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Colorectal cancer is the first neoplasm most commonly diagnosed in both sexes and the second leading cause of cancer death in Spain. Colorectal cancer screening Program in Barcelona was implanted in 2009 and approximately 1,500 colorectal cancer screening colonoscopies are performed annually at Hospital Clínic de Barcelona. Adequate colon preparation (anterograde cleansing with laxatives) improves polyp detection, decreases examination time, and complications. There are both low and high volume intestinal regimens with polyethylene glycol (PEG) as the main active ingredient or without it. Hypothesis: Two low volumen regimens, 1L PEG plus ascorbate and magnesium citrate plus picosulphate, at starting doses have the same Adenoma Detection Rate as cleansing solutions in preparation for screening colonoscopy.

Detailed Description

The primary objective of the study is to compare the clinical efficacy (by comparing the adenoma detection rate) of 1L PEG plus ascorbate versus magnesium citrate plus picosulphate in subjects undergoing colonoscopy in a colorectal cancer screening programme. We also will compare the Lesion Detection Rate, the quality of colon cleansing (Boston classification) overall and by segments, the tolerability and satisfaction and the rate of adverse effects experienced with intake of these products. Methodology: A comparative, parallel, randomized, single-centre, low-intervention clinical trial to be conducted at the CCR screening unit of Hospital Clínic de Barcelona that will include 1,002 participants. Subjects will complete a Tolerability and Satisfaction Questionnaire after completing the bowel preparation. Findings (polyps, CRC, or other lesions) and quality of bowel cleansing will be collected from the colonoscopy report.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Bowel Preparation Solutions, Screening colonoscopy, Adenoma detection rate, Tolerability, 1L PEG plus ascorbate, Magnesium citrate plus picosulphate

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

A comparative, parallel, randomized, non-inferiority, non-blinded, single-centre and low-intervention clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1002 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plenvu

Arm Type

Experimental

Arm Description

Plenvu split dose

Arm Title

Citrafleet

Arm Type

Active Comparator

Arm Description

citrafleet in split dose

Intervention Type

Drug

Intervention Name(s)

Plenvu

Other Intervention Name(s)

citrafleet

Intervention Description

randomization 1:1

Primary Outcome Measure Information:

Title

Adenoma detection rate

Description

The percentage of patients with at least one adenoma in relation to the total subjects in each group of study

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Colonoscopy quality

Description

Time Frame

2 years

Title

Lesion detection rate

Description

The percentage of patients with at least one polyp in relation to the total subjects in each group

Time Frame

2 years

Title

Caecal intubation rate

Description

If the caecum has been reached in the colonoscopy, it will be considered complete; otherwise, it will be considered incomplete

Time Frame

2 years

Title

Rate of adverse events related to the administration of the preparation

Description

Evaluated with the Tolerability and Satisfaction Questionnaire including symptoms such as nausea, vomiting, abdominal pain, bloating, headache, chills, dizziness, and dry mouth

Time Frame

2 years

Title

Tolerability and satisfaction with preparation

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 50 to 69 years who have participated in the early detection programme for colon and rectal cancer (PDPCCR) in Barcelona, who have obtained a positive result in the faecal occult blood test (≥20 μg Hb/g faeces) and who are scheduled for a screening colonoscopy at Hospital Clínic de Barcelona. Exclusion Criteria: People who do not agree to participate in the study. People with known severe renal failure (grade IV or V) and grade III and IV heart failure according to the New York Heart Association (NYHA) Scale of Functional Assessment of Heart Failure Individuals who have undergone a colonoscopy in the past year. Subjects meeting the Rome IV Criteria for the diagnosis of functional constipation Subjects with mental disabilities or with a severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders). Individuals who do not understand Catalan or Spanish verbally and in writing. Individuals with partial or total colon resection. Individuals with a personal history of CRC or colorectal disease amenable to specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas). Individuals with terminal illness or severe illness/disability that contraindicates further study of the colon. People with gastrointestinal disorders that contraindicate the use of the study products (gastric emptying disorders, perforation or gastrointestinal obstruction, ileus, toxic megacolon). People with congestive heart failure Hypermagnesemia Rhabdomyolysis Phenylketourine Glucose-6-phosphate dehydrogenase deficiency People with hypersensitivity to the active ingredients of excipients People with severe renal impairment

Facility Information:

Facility Name

Hospital CLinic

City

Barcelona

State/Province

Catalonia

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24918005

Citation

Hautefeuille G, Lapuelle J, Chaussade S, Ponchon T, Molard BR, Coulom P, Laugier R, Henri F, Cadiot G. Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study. United European Gastroenterol J. 2014 Feb;2(1):22-9. doi: 10.1177/2050640613518200.

Results Reference

background

PubMed Identifier

30025415

Citation

Schreiber S, Baumgart DC, Drenth JPH, Filip RS, Clayton LB, Hylands K, Repici A, Hassan C; DAYB Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):73-84. doi: 10.1055/a-0639-5070. Epub 2018 Jul 19.

Results Reference

background

PubMed Identifier

30025414

Citation

Bisschops R, Manning J, Clayton LB, Ng Kwet Shing R, Alvarez-Gonzalez M; MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):60-72. doi: 10.1055/a-0638-8125. Epub 2018 Jul 19.

Results Reference

background

PubMed Identifier

28803744

Citation

DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.

Results Reference

background

PubMed Identifier

29497812

Citation

Seo SI, Kang JG, Kim HS, Jang MK, Kim HY, Shin WG. Efficacy and tolerability of 2-L polyethylene glycol with ascorbic acid versus sodium picosulfate with magnesium citrate: a randomized controlled trial. Int J Colorectal Dis. 2018 May;33(5):541-548. doi: 10.1007/s00384-018-2989-7. Epub 2018 Mar 1.

Results Reference

background

PubMed Identifier

28830134

Citation

Lee SW, Bang CS, Park TY, Suk KT, Baik GH, Kim DJ. Split-dose Bowel Preparation for Colonoscopy: 2 Liters Polyethylene Glycol with Ascorbic Acid versus Sodium Picosulfate versus Oral Sodium Phosphate Tablets. Korean J Gastroenterol. 2017 Aug 25;70(2):89-95. doi: 10.4166/kjg.2017.70.2.89.

Results Reference

background

PubMed Identifier

19136102

Citation

Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

Results Reference

background

PubMed Identifier

24953203

Citation

Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep;46(9):808-12. doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19.

Results Reference

background

PubMed Identifier

30390995

Citation

Guillaumes S, O'Callaghan CA. [Spanish adaptation of the free OxMaR software for minimization and randomization of clinical studies]. Gac Sanit. 2019 Jul-Aug;33(4):395-397. doi: 10.1016/j.gaceta.2018.07.013. Epub 2018 Nov 1. Spanish.

Results Reference

background

Links:

URL

https://seom.org/ultimas-noticias/106525-las-cifras-del-cancer-en-espana-2018.

Description

URL

http://www.aegastro.es/publicaciones/publicaciones-aeg/guias-de-practica-clinica/guia-clinica-de-calidad-en-la-colonoscopia-de-cribado-del-cancer-colorrectal

Description

Guía clínica de Calidad en la Colonoscopia de Cribado del CCR

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Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy

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