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出境医 / 临床实验 / The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon

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

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.


Condition or disease Intervention/treatment Phase
Colon Adenocarcinoma Diarrhea Drug: Antibiotics Drug: Bile Acid Binder Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
Actual Study Start Date : October 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Positive breath test
Patients with a positive breath test are treated with antibiotics.
 Drug: Antibiotics
Ciprofloxacin or Rifaximin for 10 days.
Active Comparator: Positive SeHCAT scan
Patients with a positive SeHCAT scan are treated with a bile acid binder.
 Drug: Bile Acid Binder
Cholestyramine or Colesevelam lifelong.
No Intervention: No intervention
Patients with a normal breath test and a normal SeHCAT scan receive no intervention.
Outcome Measures
Primary Outcome Measures :
  1. Change in SeHCAT retention after 7 days. [ Time Frame: The SeHCAT scan consists of a baseline measurement and a measurement after 7 days. ]
    The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan.

  2. Serum concentration of FGF19 [ Time Frame: Through study completion, an average of 1 month. ]
    The serum value of FGF19 is measured by a blood sample.


Secondary Outcome Measures :
  1. Presence of bacteria in the small bowel [ Time Frame: Through study completion, an average of 1 month. ]
    The diagnosis of bacterial overgrowth in the small bowel is determined by a breath test.

  2. Symptom relief after treatment with antibiotics or bile acid binder [ Time Frame: After 3 months. ]
    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.

  3. Quality of life after treatment with antibiotics or bile acid binder [ Time Frame: After 3 months. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Helene M Larsen, MD 0045 60101648 hemala@clin.au.dk

Locations
Layout table for location information
Denmark
Department of Hepatology and Gastroenterology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Helene M Larsen, MD    0045 60101648    hemala@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Investigators
Layout table for investigator information
Study Chair: Søren Laurberg, MD DMSc Department of Surgery, Aarhus University Hospital
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Change in SeHCAT retention after 7 days. [ Time Frame: The SeHCAT scan consists of a baseline measurement and a measurement after 7 days. ]
    The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan.
  • Serum concentration of FGF19 [ Time Frame: Through study completion, an average of 1 month. ]
    The serum value of FGF19 is measured by a blood sample.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Presence of bacteria in the small bowel [ Time Frame: Through study completion, an average of 1 month. ]
    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 [ Time Frame: After 3 months. ]
    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 [ Time Frame: After 3 months. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
Official Title  ICMJE The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Colon Adenocarcinoma
  • Diarrhea
Intervention  ICMJE
  • Drug: Antibiotics
    Ciprofloxacin or Rifaximin for 10 days.
  • Drug: Bile Acid Binder
    Cholestyramine or Colesevelam lifelong.
Study Arms  ICMJE
  • Active Comparator: Positive breath test
    Patients with a positive breath test are treated with antibiotics.
    Intervention: Drug: Antibiotics
  • Active Comparator: Positive SeHCAT scan
    Patients with a positive SeHCAT scan are treated with a bile acid binder.
    Intervention: Drug: Bile Acid Binder
  • No Intervention: No intervention
    Patients with a normal breath test and a normal SeHCAT scan receive no intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Helene M Larsen, MD 0045 60101648 hemala@clin.au.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003181
Other Study ID Numbers  ICMJE 1-10-72-301-16
1-16-02-137-17 ( Other Identifier: Danish Data Protection Agency )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Danish Cancer Society
Investigators  ICMJE
Study Chair: Søren Laurberg, MD DMSc Department of Surgery, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP