LOWOL: Two Low Volume Regimens for Colorectal Cancer Screening Colonoscopy

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT04297423

Collaborator

Casen Recordati S.L. (Industry), Fundacion Clinic per a la Recerca Biomédica (Other)

1,002

Enrollment

Location

Arms

29.7

Anticipated Duration (Months)

33.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Plenvu	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1002 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 11, 2020

Anticipated Primary Completion Date :

Apr 15, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plenvu Plenvu split dose	Drug: Plenvu randomization 1:1 Other Names: citrafleet
Active Comparator: Citrafleet citrafleet in split dose	Drug: Plenvu randomization 1:1 Other Names: citrafleet

Arm

Intervention/Treatment

Experimental: Plenvu

Plenvu split dose

Drug: Plenvu

randomization 1:1

Other Names:

citrafleet

Active Comparator: Citrafleet

citrafleet in split dose

Drug: Plenvu

randomization 1:1

Other Names:

citrafleet

Outcome Measures

Primary Outcome Measures

Adenoma detection rate [1 year]
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 [1 year]
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 [1 year]
The percentage of patients with at least one polyp in relation to the total subjects in each group
Caecal intubation rate [1 year]
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 [1 year]
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 [1 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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