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

NCT01849107 | Completed

• 1 other identifier: CTR_SB_2013
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Anorexia; Dyspepsia

Keywords

Radiation-induced small bowel toxicity; Plasma citrulline

Outcome Measures

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.

  1 year

Secondary Outcomes (1)

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

  1 year

Other Outcomes (1)

• Correlation coefficient between plasma citrulline and toxicity grade by CTCAE 4.0

  1 year

Study Arms (1)

Plasma citrulline

EXPERIMENTAL

Biological: Plasma citrulline

Interventions

Plasma citrulline BIOLOGICAL

Plasma citrulline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed cancer patients
• Appropriate liver, renal, and bone marrow function for radiotherapy
• Willing to provide informed written consent
• At least 20 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (18)

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MeSH Terms

Conditions

Diarrhea; Anorexia; Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2013
• First Posted: May 8, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

KR (1)