Prevention of Acute Radiation Enteritis With Glutamine

Acute Radiation Enteritis Clinical Trial

Official title:

Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828399
• Other study ID #: 001-2008-BecaSacyl
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: May 24, 2011
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: January 2009
• Source: Castilla-León Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Radiation Enteritis
• Enteritis

Intervention

Dietary Supplement:
• Glutamine
Oral glutamine 30g/day
• Whole protein
Oral whole protein 30 g/day

Locations

Country	Name	City	State
Spain	Complejo Asistencial de León.	Leon

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View Citation

Giris 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 — View 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 prev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with acute radiation enteritis	RTOG criteria	2 months	No
Secondary	Reduction in inflammatory markers and oxydative stress		2 months	No