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

Asan Medical Center

Status: Completed

Conditions: Diarrhea; Anorexia; Dyspepsia

Treatments: Biological: Plasma citrulline

Study type: Interventional

Funder types: Other

Identifiers

NCT01849107

CTR_SB_2013

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Plasma citrulline

Experimental group

Treatment:

Biological: Plasma citrulline