Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity (NCT01849107) | Clinical Trial Compass
CompletedNot Applicable
Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
South Korea49 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serial changes in plasma citrulline level baseline, on 3rd week during, on the day of completion of radiotherapy, and 3 months post-radiotherapy.