Clincosm LogoSign in Get a demo

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

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01849107
Collaborator
(none)
49
Enrollment
1
Location
1
Arm
20
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Plasma citrulline
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Plasma citrulline

Biological: Plasma citrulline

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 138-736

Sponsors and Collaborators

  • Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Young Seok Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01849107
Other Study ID Numbers:
  • CTR_SB_2013
First Posted:
May 8, 2013
Last Update Posted:
Jan 13, 2020
Last Verified:
Jan 1, 2020
Keywords provided by Young Seok Kim, Assistant Professor, Asan Medical Center
Radiation-induced small bowel toxicity
Plasma citrulline
Additional relevant MeSH terms:
Diarrhea
Anorexia
Dyspepsia

Study Results

No Results Posted as of Jan 13, 2020