Prevention of Acute Radiation Enteritis With Glutamine

Castilla-León Health Service70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Acute Radiation Enteritis

Interventions

GlutamineDIETARY_SUPPLEMENT

Oral glutamine 30g/day

Whole proteinDIETARY_SUPPLEMENT

Oral whole protein 30 g/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Complejo Asistencial de León.

León, Leon, Spain

Outcomes

Primary Outcomes

Number of patients with acute radiation enteritis

RTOG criteria

Time frame: 2 months

Secondary Outcomes

Reduction in inflammatory markers and oxydative stress

Time frame: 2 months

Data from ClinicalTrials.gov

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