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DiarrheaNCT01849107

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

A study testing Plasma citrulline in people with Diarrhea and Anorexia, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diarrhea, Anorexia, Dyspepsia
What is being tested?
Plasma citrulline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteSouth Korea
Study dates
Apr 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

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.

Being tested
Plasma citrulline
Keywords
Radiation-induced small bowel toxicity, Plasma citrulline
Medical subject headings
Diarrhea, Anorexia, Dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plasma citrullineBiological

Study groups in NCT01849107
Study groupRoleWhat they receive
Plasma citrullineExperimentalNot described
Receives: Biological: Plasma citrulline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (1)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849107
Sponsor's protocol ID
CTR_SB_2013
Status last verified
Jan 2020
First submitted
28 Apr 2013
Last updated
13 Jan 2020
Results posted
No

Publications

  • Atahan IL, Onal C, Ozyar E, Yiliz F, Selek U, Kose F. Long-term outcome and prognostic factors in patients with cervical carcinoma: a retrospective study. Int J Gynecol Cancer. 2007 Jul-Aug;17(4):833-42. doi: 10.1111/j.1525-1438.2007.00895.x. Epub 2007 Mar 15.

    PubMed 17367320

  • Letschert JG, Lebesque JV, Aleman BM, Bosset JF, Horiot JC, Bartelink H, Cionini L, Hamers JP, Leer JW, van Glabbeke M. The volume effect in radiation-related late small bowel complications: results of a clinical study of the EORTC Radiotherapy Cooperative Group in patients treated for rectal carcinoma. Radiother Oncol. 1994 Aug;32(2):116-23. doi: 10.1016/0167-8140(94)90097-3.

    PubMed 7972904

  • Crenn P, Vahedi K, Lavergne-Slove A, Cynober L, Matuchansky C, Messing B. Plasma citrulline: A marker of enterocyte mass in villous atrophy-associated small bowel disease. Gastroenterology. 2003 May;124(5):1210-9. doi: 10.1016/s0016-5085(03)00170-7.

    PubMed 12730862

  • Lutgens LC, Deutz NE, Gueulette J, Cleutjens JP, Berger MP, Wouters BG, von Meyenfeldt MF, Lambin P. Citrulline: a physiologic marker enabling quantitation and monitoring of epithelial radiation-induced small bowel damage. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):1067-74. doi: 10.1016/s0360-3016(03)00781-8.

    PubMed 14575838

  • Crenn P, Messing B, Cynober L. Citrulline as a biomarker of intestinal failure due to enterocyte mass reduction. Clin Nutr. 2008 Jun;27(3):328-39. doi: 10.1016/j.clnu.2008.02.005. Epub 2008 Apr 28.

    PubMed 18440672

  • Herbers AH, Feuth T, Donnelly JP, Blijlevens NM. Citrulline-based assessment score: first choice for measuring and monitoring intestinal failure after high-dose chemotherapy. Ann Oncol. 2010 Aug;21(8):1706-1711. doi: 10.1093/annonc/mdp596. Epub 2010 Jan 20.

    PubMed 20089560

  • Lutgens LC, Blijlevens NM, Deutz NE, Donnelly JP, Lambin P, de Pauw BE. Monitoring myeloablative therapy-induced small bowel toxicity by serum citrulline concentration: a comparison with sugar permeability tests. Cancer. 2005 Jan 1;103(1):191-9. doi: 10.1002/cncr.20733.

    PubMed 15573372

  • Packey CD, Ciorba MA. Microbial influences on the small intestinal response to radiation injury. Curr Opin Gastroenterol. 2010 Mar;26(2):88-94. doi: 10.1097/MOG.0b013e3283361927.

    PubMed 20040865

  • Lutgens LC, Deutz N, Granzier-Peeters M, Beets-Tan R, De Ruysscher D, Gueulette J, Cleutjens J, Berger M, Wouters B, von Meyenfeldt M, Lambin P. Plasma citrulline concentration: a surrogate end point for radiation-induced mucosal atrophy of the small bowel. A feasibility study in 23 patients. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):275-85. doi: 10.1016/j.ijrobp.2004.02.052.

    PubMed 15337566

  • Kim YS, Shin SS, Nam JH, Kim YT, Kim YM, Kim JH, Choi EK. Prospective randomized comparison of monthly fluorouracil and cisplatin versus weekly cisplatin concurrent with pelvic radiotherapy and high-dose rate brachytherapy for locally advanced cervical cancer. Gynecol Oncol. 2008 Jan;108(1):195-200. doi: 10.1016/j.ygyno.2007.09.022. Epub 2007 Oct 25.

    PubMed 17963825

  • Onal C, Kotek A, Unal B, Arslan G, Yavuz A, Topkan E, Yavuz M. Plasma citrulline levels predict intestinal toxicity in patients treated with pelvic radiotherapy. Acta Oncol. 2011 Nov;50(8):1167-74. doi: 10.3109/0284186X.2011.584557. Epub 2011 Aug 24.

    PubMed 21864050

  • Kim YS, Kim JH, Ahn SD, Lee SW, Shin SS, Nam JH, Kim YT, Kim YM, Kim JH, Choi EK. High-dose extended-field irradiation and high-dose-rate brachytherapy with concurrent chemotherapy for cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1522-8. doi: 10.1016/j.ijrobp.2008.10.024. Epub 2009 Feb 21.

    PubMed 19231106

  • Kim YS, Kim JH, Yoon SM, Choi EK, Ahn SD, Lee SW, Kim JC, Yu CS, Kim HC, Kim TW, Chang HM. lymph node ratio as a prognostic factor in patients with stage III rectal cancer treated with total mesorectal excision followed by chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2009 Jul 1;74(3):796-802. doi: 10.1016/j.ijrobp.2008.08.065. Epub 2009 Mar 14.

    PubMed 19289261

  • Lee YS, Kim YS, Kim JH, Ahn SD, Lee SW, Shin SS, Nam JH, Kim YT, Kim YM, Kim JH, Choi EK. Feasibility and outcome of concurrent chemoradiotherapy for recurrent cervical carcinoma after initial surgery. Tumori. 2010 Jul-Aug;96(4):553-9. doi: 10.1177/030089161009600407.

    PubMed 20968134

  • Park JH, Kim YS, Ahn SD, Choi EK, Shin SS, Kim YT, Kim YM, Kim JH, Yi SY, Nam JH. Concurrent chemoradiotherapy or radiotherapy alone for locally advanced cervical cancer in elderly women. Tumori. 2010 Nov-Dec;96(6):959-65.

    PubMed 21388059

Questions about this trial

What is this clinical trial studying?

A study testing Plasma citrulline in people with Diarrhea and Anorexia, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01849107, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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