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

Last updated: January 8, 2020
Sponsor: Asan Medical Center
Overall Status: Completed

Phase

N/A

Condition

Heartburn

Colic

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT01849107
CTR_SB_2013
  • Ages > 20
  • All Genders

Study 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

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

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 beforeradiation

  • Any treatment delay more than 1 week during radiotherapy

  • No radiotherapy due to any other reason except small bowel toxicity

Study Design

Total Participants: 49
Study Start date:
April 01, 2013
Estimated Completion Date:
December 31, 2014

Connect with a study center

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

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