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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01849107

Enrollment

Registered

2013-05-08

Start date

2013-04-30

Completion date

2014-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia, Diarrhea, Dyspepsia

Keywords

Radiation-induced small bowel toxicity, Plasma citrulline

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.

Interventions

BIOLOGICALPlasma citrulline

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Other

Measure	Time frame
Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0	1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026