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

Not Applicable

Completed

• Conditions: Anorexia; Dyspepsia; Diarrhea

• Registration Number: NCT01849107
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-28
• Study First Submitted QC: 2013-05-05
• Study First Posted: 2013-05-08
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.	1 year

Secondary Outcome Measures

Name	Time	Method
Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.	1 year

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of