Clinical trial NCT01849107: Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Anorexia
Dyspepsia
Keywords: Radiation-induced small bowel toxicity
Plasma citrulline
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.
timeFrame: 1 year
Secondary outcomes:
measure: Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.
timeFrame: 1 year
Other outcomes:
measure: Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
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