Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity

Asan Medical Center49 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diarrhea Anorexia Dyspepsia

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

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.