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The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon

Primary Purpose

Colon Adenocarcinoma, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Antibiotics
Bile Acid Binder
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Adenocarcinoma focused on measuring Bile acid malabsorption, Small intestinal bacterial overgrowth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary adenocarcinoma in cecum or the ascending colon
  • Right-sided hemicolectomy
  • Understanding, speaking and reading Danish

Exclusion Criteria:

  • Previous major gastrointestinal, urological or gynaecological surgery or oncological treatment
  • Radiation therapy
  • Recurrence of colon cancer
  • Metastasis
  • Permanent stoma
  • Pregnancy
  • Reduced cognitive level that makes it plausible that the patient do not understand the study or is not capable of participation

Sites / Locations

  • Department of Hepatology and Gastroenterology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Positive breath test

Positive SeHCAT scan

No intervention

Arm Description

Patients with a positive breath test are treated with antibiotics.

Patients with a positive SeHCAT scan are treated with a bile acid binder.

Patients with a normal breath test and a normal SeHCAT scan receive no intervention.

Outcomes

Primary Outcome Measures

Change in SeHCAT retention after 7 days.
The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan.
Serum concentration of FGF19
The serum value of FGF19 is measured by a blood sample.

Secondary Outcome Measures

Presence of bacteria in the small bowel
The diagnosis of bacterial overgrowth in the small bowel is determined by a breath test.
Symptom relief after treatment with antibiotics or bile acid binder
This will be estimated based on self-reported symptoms: A bowel function questionnaire with 30 questions regarding different aspects of bowel function. The patients should state if they have the symptoms daily, 1-6 times per week, less than once a week, or never.
Quality of life after treatment with antibiotics or bile acid binder
This will be estimated based on self-reported symptoms: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0. A questionnaire with 30 individual questions summing up to form one global health status, five functional subscales, three symptom scales and six single items addressing different aspects of quality of life. The scales range from 0-100 with a higher score representing a higher level of functioning or a higher degree of symptoms, respectively.

Full Information

First Posted
April 23, 2019
Last Updated
August 31, 2021
Sponsor
University of Aarhus
Collaborators
Danish Cancer Society, GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04003181
Brief Title
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
Official Title
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Danish Cancer Society, GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many patients suffer from chronic diarrhoea after surgical treatment for cancer in the right side of the colon. The investigators' main hypothesis is that colon cancer patients with chronic diarrhoea have a higher risk of bile acid malabsorption compared with colon cancer patients without diarrhoea. The investigators also expect that a part of the cases of bile acid malabsorption is caused by underlying bacterial overgrowth in the small bowel. The investigators assume that patients with severe bile acid malabsorption have a lower value of FGF19 in the blood compared to patients with moderate or none bile acid malabsorption. Furthermore, it is assumed that patients with chronic diarrhoea and documented bile acid malabsorption after surgical treatment for right-sided colon cancer will get improved bowel function when treated with a bile acid binder, or antibiotics in case of bacterial overgrowth.
Detailed Description
Patients with chronic diarrhoea after surgical treatment of right-sided colon cancer will be compared to patients without diarrhoea after right-sided colon cancer treatment. All patients will be asked to answer a short questionnaire regarding bowel function, and they will all have standard blood tests taken to exclude non-cancer related causes of diarrhoea. Besides these standard tests, the value of FGF19 will be measured in a blood sample from the fasting participants. All participants will undergo SeHCAT scan to determine the presence of bile acid malabsorption among right-sided colon cancer patients with and without diarrhoea. In addition, a glucose breath test will be performed to examine, if the patients have small intestinal bacterial overgrowth. Patients with a positive glucose breath test, and thus bacterial overgrowth, will be treated with antibiotics, followed by another SeHCAT scan, glucose breath test, and measurement of gastrointestinal transit time. In addition, they will be asked to complete the questionnaire regarding bowel function again. All cases with an abnormal SeHCAT scan will be treated with a bile acid binder, and the patients will be asked to complete the questionnaire one more time, and the GITT measurement will be repeated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenocarcinoma, Diarrhea
Keywords
Bile acid malabsorption, Small intestinal bacterial overgrowth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive breath test
Arm Type
Active Comparator
Arm Description
Patients with a positive breath test are treated with antibiotics.
Arm Title
Positive SeHCAT scan
Arm Type
Active Comparator
Arm Description
Patients with a positive SeHCAT scan are treated with a bile acid binder.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patients with a normal breath test and a normal SeHCAT scan receive no intervention.
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Ciprofloxacin or Rifaximin for 10 days.
Intervention Type
Drug
Intervention Name(s)
Bile Acid Binder
Intervention Description
Cholestyramine or Colesevelam lifelong.
Primary Outcome Measure Information:
Title
Change in SeHCAT retention after 7 days.
Description
The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan.
Time Frame
The SeHCAT scan consists of a baseline measurement and a measurement after 7 days.
Title
Serum concentration of FGF19
Description
The serum value of FGF19 is measured by a blood sample.
Time Frame
Through study completion, an average of 1 month.
Secondary Outcome Measure Information:
Title
Presence of bacteria in the small bowel
Description
The diagnosis of bacterial overgrowth in the small bowel is determined by a breath test.
Time Frame
Through study completion, an average of 1 month.
Title
Symptom relief after treatment with antibiotics or bile acid binder
Description
This will be estimated based on self-reported symptoms: A bowel function questionnaire with 30 questions regarding different aspects of bowel function. The patients should state if they have the symptoms daily, 1-6 times per week, less than once a week, or never.
Time Frame
After 3 months.
Title
Quality of life after treatment with antibiotics or bile acid binder
Description
This will be estimated based on self-reported symptoms: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0. A questionnaire with 30 individual questions summing up to form one global health status, five functional subscales, three symptom scales and six single items addressing different aspects of quality of life. The scales range from 0-100 with a higher score representing a higher level of functioning or a higher degree of symptoms, respectively.
Time Frame
After 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary adenocarcinoma in cecum or the ascending colon Right-sided hemicolectomy Understanding, speaking and reading Danish Exclusion Criteria: Previous major gastrointestinal, urological or gynaecological surgery or oncological treatment Radiation therapy Recurrence of colon cancer Metastasis Permanent stoma Pregnancy Reduced cognitive level that makes it plausible that the patient do not understand the study or is not capable of participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Laurberg, MD DMSc
Organizational Affiliation
Department of Surgery, Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Hepatology and Gastroenterology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon

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