Clinical trial NCT00828399: Prevention of Acute Radiation Enteritis With Glutamine
Official title: Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Radiation Enteritis
Keywords: Radiotherapy
Diarrhoea
Glutamine
Oxydative stress
Calprotectin
Citrulline
Lead sponsor: Castilla-León Health Service
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. The investigators designed a randomized, double-blind trial phase III to study if glutamine prevents acute radiation enteritis.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 yr
* Gynaecological,prostatic, rectal or other abdominal cancer
* Radiotherapy with/without chemotherapy

Exclusion Criteria:

* life expectancy \< 1 yr
* Age \< 18 yr
* gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
* moderate to severe chronic renal failure
* hepatic cirrhosis

Primary outcomes:
measure: Number of patients with acute radiation enteritis
timeFrame: 2 months
Secondary outcomes:
measure: Reduction in inflammatory markers and oxydative stress
timeFrame: 2 months
Other outcomes:
Locations:
city: Leon
country: Spain
facility: Complejo Asistencial de León.
Study officials:
affiliation: Sección de Endocrinología y Nutrición. Complejo Asistencial de León
name: Alfonso Vidal Casariego, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, Engeler GP, Frank AR, McKone TK, Urias RE, Pilepich MV, Novotny PJ, Martenson JA; North Central Cancer Treatment Group. Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol. 2003 May 1;21(9):1669-74. doi: 10.1200/JCO.2003.05.060.
citation: Giris M, Erbil Y, Oztezcan S, Olgac V, Barbaros U, Deveci U, Kirgiz B, Uysal M, Toker GA. The effect of heme oxygenase-1 induction by glutamine on radiation-induced intestinal damage: the effect of heme oxygenase-1 on radiation enteritis. Am J Surg. 2006 Apr;191(4):503-9. doi: 10.1016/j.amjsurg.2005.11.004.
citation: Ersin S, Tuncyurek P, Esassolak M, Alkanat M, Buke C, Yilmaz M, Telefoncu A, Kose T. The prophylactic and therapeutic effects of glutamine- and arginine-enriched diets on radiation-induced enteritis in rats. J Surg Res. 2000 Apr;89(2):121-5. doi: 10.1006/jsre.1999.5808.
citation: de Urbina JJ, Jorquera F, Culebras JM, Villares C, Gonzalez-Gallego J, Tunon MJ. Effects of parenteral nutrition supplemented with alanyl-glutamine on nutrition status in rats. JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4):262-5. doi: 10.1177/0148607105029004262.