Prevention of Acute Radiation Enteritis With Glutamine

Phase 4

Completed

• Conditions: Acute Radiation Enteritis
• Interventions: Dietary Supplement: Glutamine; Dietary Supplement: Whole protein

• Registration Number: NCT00828399
• Lead Sponsor: Castilla-León Health Service

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-24
• Last Update Posted: 2011-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine	Glutamine	-
Whole protein	Whole protein	-

Primary Outcome Measures

Name	Time	Method
Number of patients with acute radiation enteritis	2 months	RTOG criteria

Secondary Outcome Measures

Name	Time	Method
Reduction in inflammatory markers and oxydative stress	2 months

Trial Locations

Locations (1)

Complejo Asistencial de León.; 🇪🇸 Leon, Spain