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Completed

NCT Number: NCT01849107

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

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.

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Key information

Conditions

Diarrhea Anorexia Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma citrulline

Biological

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Correlation coefficient between plasma citrulline and dose-volume histogram of small bowel.

    Time frame: 1 year

Other outcomes

  1. Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 8, 2013
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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