Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Plasma citrulline
Intervention: Plasma citrulline (Biological)
Outcomes
Primary Outcomes
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 Outcomes
- Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.(1 year)
Investigators
Young Seok Kim
Assistant Professor
Asan Medical Center