Diarrhea — Plasma Citrulline: A Marker for Monitoring & Quantifying Radiation-Induced Small Bowel Toxicity
Citation(s)
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. Epub 2007 Mar 15.
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. Review.
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):1706-11. doi: 10.1093/annonc/mdp596. Epub 2010 Jan 20.
Kim JY, Kim JY, Kim JH, Yoon MS, Kim J, Kim YS Curative chemoradiotherapy in patients with stage IVB cervical cancer presenting with paraortic and left supraclavicular lymph node metastases. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):741-7. doi: 10.1016/j.ijrobp.2012.01.070. Epub 2012 Aug 14.
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.
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. Epub 2007 Oct 25.
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.
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. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
