Prevention of Acute Radiation Enteritis With Glutamine - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Radiation Enteritis	Dietary Supplement: Glutamine Dietary Supplement: Whole protein	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Glutamine

U.S. FDA Resources

Further study details as provided by Castilla-León Health Service:

Primary Outcome Measures:

Number of patients with acute radiation enteritis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
RTOG criteria

Secondary Outcome Measures:

Reduction in inflammatory markers and oxydative stress [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	January 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Glutamine	Dietary Supplement: Glutamine Oral glutamine 30g/day
Placebo Comparator: Whole protein	Dietary Supplement: Whole protein Oral whole protein 30 g/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828399

Locations

Spain
Complejo Asistencial de León.
Leon, Spain, 24008

Sponsors and Collaborators

Castilla-León Health Service

Investigators

Principal Investigator:

Alfonso Vidal Casariego, MD

Sección de Endocrinología y Nutrición. Complejo Asistencial de León

More Information

Publications:

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.

Giriş M, Erbil Y, Oztezcan S, Olgaç 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.

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.

de Urbina JJ, Jorquera F, Culebras JM, Villares C, González-Gallego J, Tuñón 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.

Responsible Party:	MD Alfonso Vidal Casariego, Complejo Asistencial de Leóm
ClinicalTrials.gov Identifier:	NCT00828399 History of Changes
Other Study ID Numbers:	001-2008-BecaSacyl
Study First Received:	January 22, 2009
Last Updated:	May 24, 2011
Health Authority:	Spain: Ethics Committee

Keywords provided by Castilla-León Health Service:

Radiotherapy
Diarrhoea
Glutamine

Oxydative stress
Calprotectin
Citrulline

Additional relevant MeSH terms:

Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013