Evaluating the Association of Inflammatory Response to Intestinal Leakage in Patients Receiving Chemotherapy for Stage 3 Colon Cancer

Overview

About this study

To study intestinal permeability in participants with stage 3 colon cancer before and during chemotherapy and compare with controls with normal colon, chronic ulcerative colitis (CUC) and carcinoid syndrome

To study the correlation between intestinal permeability and symptoms severity during 5-FU chemotherapy

To study the correlation between intestinal permeability and neutrophils to lymphocytes ratio (NLR) before and during chemotherapy

To analyze the changes in expression levels of genes encoding intercellular junction proteins in all groups

To determine if diarrhea in participants with carcinoid syndrome is associated with increasedintestinal permeability

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Age ≥18 years, male or female

For the Colon cancer subjects: Diagnosis of stage 3 colon cancer without IBD before treatment, during treatment with 5-FU based chemotherapy and post treatment.

Normal colon participants :  Normal colonoscopy without current adenomatous polyps, IBD, critical illness, obesity, celiac disease, NASH, IBS, food allergy, malnutrition or current history of diarrhea. 

Polyp participants; participants with advanced adenoma (> 1cm in size; villous histology and/or high grade dysplasia without IBD

Active Chronic ulcerative colitis:  participants with active CUC.

Carcinoid syndrome: participants with carcinoid syndrome.

Can swallow the mannitol capsule and drink up to 200 ml of water (or approximately 8 cups) and agrees to undergo urine testing up to 3 times during the study.

Exclusion Criteria

Participants with prior GI tract surgical (small or large bowel) resections

For normal colon participants: no h/o IBD critical illness, obesity, celiac disease, NASH, IBS, food allergy, malnutrition or current history of diarrhea.

Women who are pregnant or breast-feeding

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Lisa Boardman, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20306554

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