Prevention of Acute Radiation Enteritis With Glutamine

Castilla-León Health Service

Status and phase: Completed; Phase 4

Conditions: Acute Radiation Enteritis

Treatments: Dietary Supplement: Glutamine; Dietary Supplement: Whole protein

Study type: Interventional

Funder types: Other

Identifiers

NCT00828399

001-2008-BecaSacyl

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Glutamine

Experimental group

Treatment:

Dietary Supplement: Glutamine

Whole protein

Placebo Comparator group

Treatment:

Dietary Supplement: Whole protein