Back to resultsPlasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
Primary Purpose
Diarrhea, Anorexia, Dyspepsia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Plasma citrulline
Sponsored by
About this trial
This is an interventional diagnostic trial for Diarrhea focused on measuring Radiation-induced small bowel toxicity, Plasma citrulline
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed cancer patients
- Appropriate liver, renal, and bone marrow function for radiotherapy
- Willing to provide informed written consent
- At least 20 years old
Exclusion Criteria:
- prior abdominopelvic radiation therapy or chemotherapy or abdominal surgery
- Any contraindication to radiotherapy (i.e. Severe connective tissue disorder, etc.)
- Prior or simultaneous history of other malignancy
- On medication for small bowel disease or CTCAE 4.0 Grade 1 or higher toxicity before radiation
- Any treatment delay more than 1 week during radiotherapy
- No radiotherapy due to any other reason except small bowel toxicity
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plasma citrulline
Arm Description
Outcomes
Primary Outcome Measures
Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
Secondary Outcome Measures
Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01849107
Brief Title
Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
5. Study Description
Brief Summary
Small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. A metabolic end product of small bowel enterocytes is plasma citrulline. The investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Anorexia, Dyspepsia
Keywords
Radiation-induced small bowel toxicity, Plasma citrulline
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasma citrulline
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Plasma citrulline
Primary Outcome Measure Information:
Title
Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed cancer patients
Appropriate liver, renal, and bone marrow function for radiotherapy
Willing to provide informed written consent
At least 20 years old
Exclusion Criteria:
prior abdominopelvic radiation therapy or chemotherapy or abdominal surgery
Any contraindication to radiotherapy (i.e. Severe connective tissue disorder, etc.)
Prior or simultaneous history of other malignancy
On medication for small bowel disease or CTCAE 4.0 Grade 1 or higher toxicity before radiation
Any treatment delay more than 1 week during radiotherapy
No radiotherapy due to any other reason except small bowel toxicity
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
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Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
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